ENCORE News Archives - ENCORE Research Group

On July 2, 2024, the US FDA approved Kisunla (kih-SUHN-lah, donanemab-azbt) for the treatment of Alzheimer’s disease in people with early symptomatic Alzheimer’s disease. A characteristic marker of Alzheimer’s is amyloid plaques. These plaques are caused by an accumulation of naturally occurring amyloid protein and deposits in the brain, affecting cognition, memory, and executive function. Kisunla is a monthly injection that targets amyloid plaques. Kisunla helps the body remove excess amyloid, resulting in an average 61%-84% reduction of plaques, depending on the length of treatment. Alzheimer’s treatments have the greatest potential effects the earlier in the disease timeline they are implemented. Kisunla is approved for people with mild cognitive impairment (MCI) and those with mild Alzheimer’s dementia with a confirmed amyloid pathology. Jacksonville Center for Clinical Research participated in the TRAILBLAZER clinical trials. Eli Lilly and Company says Kisunla should be available to authorized specialty distributors for ordering this month.

Source: https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early

On June 25th, 2024, Flourish Research, a portfolio company of NMS Capital, announced its partnership with ENCORE™ Research Group. Dr. Michael Koren, founder and CEO of ENCORE™, has scaled the organization significantly since its inception in 1997. ENCORE™ is comprised of an extensive physician network in Northern and Western Florida that provides an effective and differentiated approach to clinical research. ENCORE™ has conducted 3,200+ clinical trials across 50+ therapeutic areas.

Excerpt from NMS/Flourish press release:

Dr. Koren said, “We have been very impressed during our interactions with the Flourish team and feel confident that we’ve found the right partner for our next phase of growth. Our staff and extensive network of physician investigators have expressed enthusiasm about our future with Flourish, working together to provide the best clinical trial services as part of a national company.”

CEO of Flourish Research, Reinhold Schulz, added, “We are excited to welcome ENCORE™ to the Flourish family. I’ve gotten to know Dr. Koren and his key lieutenants very well and the cultural fit was evident from our initial meetings. ENCORE™ brings expertise that will be additive to Flourish and has a robust backlog and pipeline of studies that will bring immediate value to the combined organization.”

Senior Partner at NMS Capital, Luis Gonzalez, stated “The partnership with ENCORE™ further enhances Flourish’s geographic footprint and capabilities in its core therapeutic areas while bringing a deep bench of scientific thought leaders. The transformative partnership will provide ENCORE™ the opportunity to leverage the significant infrastructure investment Flourish has made in its differentiated patient recruitment, commercial, and diversity strategy. This approach will result in a win-win for our patients, employees, and biopharma customers”

NMS Capital, formed in 2010, is a private equity firm with $1.5+ billion in assets under management. NMS Capital focuses on driving sustainable growth for healthcare and business service companies.

Please visit the company websites for more details:

ENCOREdocs.com/

flourishresearch.com/

nms-capital.com/

On May 31, 2024, The US FDA approved Moderna’s mRESVIA(R) respiratory syncytial virus (RSV) vaccine for adults over 60 years of age. RSV is a highly contagious virus that infects the lower lungs and can cause pneumonia. It causes thousands of deaths per year among older patients in the United States. One of the major structures needed for RSV to infect a host cell is the fusion, or F glycoprotein. This structure enables the virus to merge with human cells and deliver its contents. mRESVIA(R) is an mRNA vaccine, the first mRNA vaccine to be approved other than for COVID-19. This vaccine instructs our cells to recognize and destroy the F glycoprotein present on RSV, providing significant protection of the lower airway from infection. Jacksonville Center for Clinical Research and Fleming Island Center for Clinical Research participated in the Phase II ConquerRSV Trials. Moderna expects mRESVIA(R) to be available for the 2024-2025 RSV season.

Sources: https://investors.modernatx.com/news/news-details/2024/Moderna-Receives-U.S.-FDA-Approval-for-RSV-Vaccine-mRESVIAR/default.aspx

On March 14, 2024, the US FDA granted accelerated approval for Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) with diet and exercise for the treatment of Nonalcoholic Steatohepatitis (NASH), also known as Metabolic Dysfunction-Associated Steatohepatitis (MASH). NASH, a form of fatty liver, affects around 5% of adults in the United States and can lead to debilitating liver failure over the long term. Rezdiffra selectively activates thyroid hormone receptor-β. When combined with diet and exercise, this significantly decreases liver fibrosis and can lead to NASH resolution. Rezdiffra has been the target medication of multiple clinical trials at ENCORE Research Group sites. Jacksonville Center for Clinical Research, Nature Coast Clinical Research – Inverness, and St. Johns Center for Clinical Research have all participated in trials involving Rezdiffra. Madrigal expects Rezdiffra to be available to limited pharmacies in April 2024.

Source:

https://ir.madrigalpharma.com/news-releases/news-release-details/madrigal-pharmaceuticals-announces-fda-approval-rezdiffratm

Clinical researchers (including our very own Dr. Michael J. Koren) have recently confirmed the success of an oral PCSK9 inhibitor in lowering cholesterol in patients who are taking the maximum amount of currently approved cholesterol medications. PCSK9 is short for proprotein convertase subtilisin/kexin type 9. This protein lowers the liver’s ability to break down LDL cholesterol, so by inhibiting (decreasing) PCSK9, the liver is more effective. All PCSK9 inhibitors that are currently approved must be injected, so an oral medication that successfully inhibits PCSK9 is a big step forward. In the current study, patients on the oral PCSK9 inhibitor saw similar drops in LDL cholesterol to the injectable medication! Remember that this is in patients who were already on the maximum dose of approved oral cholesterol medications!

To find out more, the study is available at:

https://www.thelancet.com/journals/landia/article/PIIS2213-8587(23)00325-X/abstract

On November 10, 2023, the US FDA approved Valneva’s IXCHIQ chikungunya vaccine for adults 18 and older who are at an increased risk. Chikungunya is a mosquito-borne disease caused by the chikungunya virus. Outbreaks are unpredictable and rapid. Though it is not endemic to the United States, it has still infected millions of Americans over the past 10 years. Overall mortality is low, but morbidity is high with symptoms including fever, joint pain which may become chronic, and rash. IXCHIQ is a live-attenuated vaccine and is the world’s first to be approved. It targets all viral strains. St. Johns Center for Clinical Research participated in two phase three clinical trials testing safety, efficacy, and consistency of the vaccine. Valneva expects IXCHIQ to be available commercially by early 2024.

Sources:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00641-4/fulltext

https://valneva.com/wp-content/uploads/2023/11/2023_11_10_BLA_Approval_PR_EN_Final_.pdf

On November 1st, 2023, the US FDA approved Phathom Pharmaceuticals’ VOQUEZNA for healing treatment of erosive Gastroesophageal Reflux Disease (GERD). Around 20% of people suffer from GERD, where stomach acid moves up into the esophagus. With erosive GERD, this acid reflux causes damage to throat tissue. This is painful, but can also lead to complications and a worsening condition. Though current medications exist, over half of patients with erosive GERD continue to have symptoms. Potassium-competitive acid blockers (PCABs) are a new class of acid-fighting medications that block acid production in the stomach. These have been called the “next generation” of proton-pump inhibitors. VOQUEZNA is a PCAB medication and has shown superior activity in clinical trials. ENCORE Research Group is proud to have participated at two sites, ENCORE Borland Groover Clinical Research in Jacksonville, FL and Nature Coast Clinical Research in Inverness, FL. Phathom Pharmaceuticals expects the VOQUEZNA to be commercially available in December, 2023.

Source: https://investors.phathompharma.com/news-releases/news-release-details/phathom-pharmaceuticals-announces-fda-approval-voqueznar

FDA-Approves-Pfizers-RSV-Vaccine-For-Older-Adults-1000-×-667-px.png

On May 31, 2023, the US FDA approved Pfizer’s ABRYSVO Respiratory Syncytial Virus (RSV) Vaccine for adults 60 and older. RSV is a serious respiratory concern for older adults, resulting in tens of thousands of hospitalizations and thousands of deaths annually. The F protein is on the outside of Respiratory Syncytial Virus and allows it to attach (or fuse) to a target human cell. ABRYSVO targets this protein before it fuses to a cell (in its perfusion state), and is effective against both the A and B strains of RSV. Thus ABRYSVO is a bivalent (targeting 2 strains) prefusion F protein-based vaccine. The vaccine was also granted Breakthrough Therapy Designation in February and is the only vaccine intended as both a protective (before infection) and a therapeutic (to stop infection and relieve symptoms). Nature Coast Clinical Research in Crystal River, Florida participated in clinical trials researching this vaccine. ABRYSVO was found to be safe and effective in older populations. Pfizer expects ABRYSVO to be available before fall 2023 and the start of RSV season.

Source: https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-abrysvotm-pfizers-vaccine-prevention?linkId=217543918

On May 26, 2023, Lexicon Pharmaceuticals’ INPEFA (sotagliflozin) was approved by the US FDA with broad label uses for treatment of heart failure. Heart failure is a significant, debilitating condition where the heart does not deliver enough oxygen to the cells in the body. It affects over 6 million Americans and hospitalizes over a million Americans per year. INPEFA has been shown to reduce cardiovascular death, hospitalization, and urgent heart failure by 33% when compared with placebo. It is approved in patients with left ventricular ejection fraction (LVEF) and for adults with cardiovascular risk factors, including type 2 diabetes and chronic kidney disease. INPEFA is a sodium-glucose cotransporter inhibitor and affects glucose regulation. Jacksonville Center for Clinical Research participated in the SOLOIST and SCORED clinical trials which were critical in showing the effectiveness of INPEFA. Lexicon expects INPEFA to be available by the end of June, 2023.

Source: https://www.lexpharma.com/media-center/news/2023-05-26-lexicon-announces-fda-approval-of-inpefa-sotagliflozin-for-treatment-of-heart-failure

On May 18, 2023, the US FDA approved AbbVie’s RINVOQ (upadacitinib) as a daily pill for adults with moderate or severe Crohn’s disease. Crohn’s disease is an autoimmune disorder causing inflammation anywhere between the mouth and anus and is frequently interspersed with healthy tissue. It can cause wide-ranging, often painful GI and oral symptoms. RINVOQ is a selective tyrosine kinase inhibitor that has been approved in six other applications from rheumatoid arthritis to ulcerative colitis. RINVOQ is now the first approved oral treatment for moderate to severe Crohn’s disease. ENCORE Borland Groover Clinical Research participated in phase III trials to determine safety and efficacy in moderate and severe Crohn’s patients who did not respond to other treatments.

Source: https://news.abbvie.com/news/press-releases/us-fda-approves-rinvoq-upadacitinib-as-once-daily-pill-for-moderately-to-severely-active-crohns-disease-in-adults.htm

On May 13, 2023, Astellas’ VEOZAH was approved by the FDA. VEOZAH, also known as fezolinetant, is the first non-hormonal treatment for moderate to severe vasomotor symptoms in women with menopause. Vasomotor symptoms are the most common symptoms of menopause, affecting between 60-80% of women.They include hot flashes and night sweats, and are thought to be due to an imbalance of estrogen and neurokinin B. Unlike estrogen supplication, VEZOAH targets neurokinin B receptors in the temperature regulation center of the brain, the hippocampus. Three ENCORE Research Group centers participated in the pivotal SKYLIGHT trials to investigate efficacy and safety of VEZOAH: the Fleming Island Center for Clinical Research, St. Johns Center for Clinical Research, and Nature Coast Clinical Research – Crystal River. These three centers also participated in the SKYLIGHT 4 trial to study long-term safety.

Source:

https://www.astellas.com/en/system/files/news/2023-05/20230513_en_1.pdf

On May 3, 2023, the FDA issued approval for GlaxoSmithKline’s (GSK) Arexvy RSV vaccine for adults 60 and older. RSV is a respiratory virus that hospitalizes around 177,000 adults over 65 each year, with 14,000 resulting in death. Arexvy is an adjuvanted recombinant glycoprotein antigen and the first RSV vaccine to be approved in adults. Clinical trials have shown efficacy above 82% in older adults and over 94% in those with relevant medical conditions. The Westside Center for Clinical Research, an ENCORE Research Group clinical site, has been participating in the Phase III study to show efficacy and safety of Arexvy against placebo treatment. GSK aims to make the vaccine available for adults over 60 before the end of 2023.

Source:

https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-gsk-s-arexvy-the-world-s-first-respiratory-syncytial-virus-rsv-vaccine-for-older-adults/

On April 26, 2023, The US FDA announced approval of VOWST, formerly known as SER-109, for preventing recurrence of C. difficile. C. difficile is a major health threat, with 200,000 cases in American hospitals and over 12,000 deaths per year. VOWST is an orally administered microbiota-based medication and is the first of its kind to be approved. Clinical trials found that VOWST reduced the recurrence of C. difficile at rates nearly 50% higher than placebo controls. Studies found this at both 8 weeks and 6 months after intervention. ENCORE Borland Groover Clinical Research participated in the clinical trials ECOSPOR III and ECOSPOR IV and helped pave the way for this exciting, safe, and effective new medication. Nestlé Health Science and Seres Therapeutics expect VOWST to be available by June of 2023.

Sources:

https://www.nestlehealthscience.us/stories/seres-therapeutics-and-nestle-health-science-announce-fda-approval-vowst

Respiratory Syncytial Virus (RSV) is a highly infectious disease which is particularly dangerous for infant and elderly patients. It is one of the major infectious diseases without an approved vaccine, so the effort to develop vaccines has been underway.

To combat this ongoing and widespread disease, companies have been developing vaccines targeting the prefusion F glycoprotein. Prefusion F proteins are RSV surface proteins required for viral fusion into host cells. This is the most promising target for vaccine research.

GlaxoSmithKline has found preliminary success in its RSVPreF3 OA investigational vaccine in patients over 60 years of age. Their Phase 3, placebo-controlled study is ongoing in nearly 25 thousand participants around the world, including those participants at the Westside Center for Clinical Research, part of ENCORE Research Group.

Recently published results show a significant protective effect of the vaccine, lowering infections by 82% and severe infections by over 94%, all with a favorable safety profile. This will help lower the incidence and hospitalization of RSV in patients and underscores the importance of clinical research and the work of ENCORE Research Group, its sponsors, physicians, staff, and participants in the clinical research process.

Sources:

Bergeron, H. C., & Tripp, R. A. (2021). Immunopathology of RSV: an updated review. Viruses, 13(12), 2478. https://doi.org/10.3390/v13122478

Killikelly, A. M., Kanekiyo, M., & Graham, B. S. (2016). Pre-fusion F is absent on the surface of formalin-inactivated respiratory syncytial virus. Scientific reports, 6(1), 1-7. https://doi.org/10.1038/srep34108

Papi, A., Ison, M. G., Langley, J. M., Lee, D. G., Leroux-Roels, I., Martinon-Torres, F., … & Hulstrøm, V. (2023). Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. New England Journal of Medicine, 388(7), 595-608. https://doi.org/10.1056/NEJMoa2209604

Two ENCORE Research Group sites, Nature Coast Clinical Research and ENCORE Borland Groover Clinical Research, played a vital role in the clinical trials for “Vibrant,” a new vibrating drug-free capsule designed to treat constipation. In August 2022, the product received clearance from the FDA to be marketed and used for the treatment of constipation. The capsule recently became available for prescriptions as of February 2023.

Vibrant’s unique drug-free treatment works by using gentle vibrations to stimulate the colon mechanically, thus improving its natural motility. The pre-programmed timing of the vibrations is based on the colon’s biological clock, which makes the treatment effective and gentle.

Vibrant’s Phase 3 clinical trial results showed an increased number of complete bowel movements and an improvement in patients’ quality of life. The trial also reported a low incidence of diarrhea at just 1.2%.

It’s important to note that Vibrant is a prescription-only treatment, and it should be recommended by a physician based on the patient’s medical needs and suitability. The treatment’s effectiveness and low incidence of side effects make it a promising option for those struggling with constipation.

Sources:

https://www.vibrantgastro.com/

https://www.medscape.com/

Heart disease is one of the leading causes of death worldwide, and researchers are constantly searching for new treatments to reduce the risk of cardiovascular events. One area of interest is lipoprotein (a), or Lp(a), a molecule that has been associated with an increased risk of heart disease.

To tackle this issue, Amgen has developed a new investigational drug called Olpasiran, a small interfering RNA designed to lower the body’s production of apolipoprotein(a), a key component of Lp(a). Currently, Olpasiran is being studied in Phase III clinical trials, with Jacksonville Center for Clinical Research (JCCR) and Jacksonville physicians playing a significant role in the clinical research trials.

The development of Olpasiran holds important public health implications for the future of Lp(a) treatment and is a testament to the impact that JCCR and its clinical partners are making in advancing medical progress. By participating in the clinical trials of Olpasiran, JCCR is contributing to the discovery of new treatments that have the potential to improve the lives of millions of people.

Olpasiran development represents a significant step forward in the treatment of Lp(a), and JCCR’s involvement in the clinical research trials underscores the important role that clinical research plays in advancing medical knowledge and improving public health.

Sources:

https://www.pharmaceutical-technology.com/data-insights/olpasiran-what-is-the-likelihood-that-drug-will-be-approved/

https://www.amgen.com/

ENCORE Research Group is proud to announce that it has three highly-skilled and accomplished physicians with the prestigious ACRP Certified Principal Investigator (CPI) credential: Dr. Michael J. Koren, Dr. Kyle Etzkorn, and Dr. Victoria Helow.

This trusted mark of excellence recognizes the expertise and experience of clinical research professionals. To earn the credential, investigators must have 3,000 hours of verifiable work experience as a principal or sub-investigator on multiple studies. They must also pass a standardized certification exam, testing their knowledge and skills in the field.

By having three physicians with the CPI credential on its team, ENCORE Research Group is able to offer sponsors high-level quality clinical research services. These physicians bring a wealth of knowledge, skill, and insight to the company, and they are well-equipped to lead clinical trials and research projects with confidence and competence.

In a field that is constantly evolving and advancing, it is essential to have professionals who are up-to-date on the latest industry developments and who can deliver results that are reliable and trustworthy. The CPI credential is a testament to our physicians’ commitment to excellence in their field, and it is a reflection of the level of care and dedication that they bring to their work.

Click here for Academy of Clinical Research Professionals CPI Certification Information.

Listen to the article here:

ENCORE · Celebrating 26 Years Of Service To The Florida Community

We are proud to announce that Jacksonville Center for Clinical Research, a member of the ENCORE Research Group, is celebrating 26 years of advancing medical research in Florida. Our team of over 100 collaborating physicians have conducted over 2700 studies with 130,000 patients, solidifying our position as the premier clinical research organization in the community.

Our compassionate approach and decades of experience ensure that each patient’s journey through clinical research is safe, beneficial, streamlined and personalized. Our commitment to quality and safety has earned us the trust of our community and we are honored to continue serving them.

When you make the decision to volunteer to participate in a clinical research trial, JCCR and ENCORE Research Group are here to guide you every step of the way. Our team is dedicated to providing a supportive and safe environment, and we are proud to bring you into our community of heroes.

We would like to thank our patients, physicians, and staff for their continued support and trust in our services. Here’s to another 26 years of making a difference in the lives of our community!

Nature Coast Clinical Research Announces the Remodeling of Its Inverness, Florida Office, Now Offering Phase 1 Clinical Trial Capabilities

Inverness, Florida – Nature Coast Clinical Research is pleased to announce the completion of our remodeled office in Inverness, Florida, across the street from Citrus HCA Hospital. The fully renovated facility, located at 411 West Highland Boulevard, features new, state-of-the-art equipment and trained staff that allows for an expanded selection of clinical trials.

The remodeling project was undertaken to expand and modernize our research capabilities providing the opportunity for members of the community to participate in all phases of clinical trials. Nature Coast Clinical Research now features a dedicated Phase 1 unit, which includes private inpatient rooms for overnight stays, on-site lifesaving medication and equipment, and certified, trained staff in-house 24/7. The office also has multiple newly renovated, cutting-edge outpatient examination rooms for later-phase trials and non-overnight office visits.

Phase 1, or early phase clinical trials, are used to test the safety of new investigational drugs or devices by helping to determine the correct dosage of new investigational treatments. They are a critical step in the clinical trial process and often require that patients complete overnight stays in the unit.

Phase 2-4, or later phase clinical trials, are conducted on investigational medications or devices that have successfully completed earlier phase trials. They further look at safety parameters as well as dosing regimens, and the effectiveness of investigational therapies and devices.

Nature Coast Clinical Research is part of ENCORE Research Group, a full-service clinical research organization with locations throughout the state of Florida specializing in conducting Phase 1-4 clinical trials for Alzheimer’s, digestive issues, fatty liver, cardiovascular diseases, vaccines, and more. We are committed to providing patients in the community access to the latest treatments and therapies through clinical research studies.

Dr. Rafik Abadier, the medical director of Nature Coast Clinical Research’s Inverness Phase 1 unit, is board-certified and has been practicing cardiology for more than twenty-five years. He has been a Principal Investigator of multiple clinical trials since 2007.

Dr. Paul Hellstern, the medical director of Nature Coast Clinical Research’s Inverness Outpatient office, is board-certified in internal medicine and gastroenterology. He has been a Principal Investigator of multiple clinical trials since 2000.

The remodeled office is now open for business and is accepting patients for all phases of clinical trials. Watch this space to learn more about Nature Coast Clinical Research and our new Phase 1 options!

Contact Jill Livingston, Phase 1 Unit Manager, for more information.

(352) 341-2100

Nature Coast Clinical Research – Inverness

411 West Highland Boulevard Inverness, FL 34452

Main Office: (352) 341-2100

Resmetirom is an investigational oral medication aimed at reducing the symptoms and reversing the effects of Non-alcoholic steatohepatitis (NASH), an advanced form of non-alcoholic fatty liver disease. The medication is delivered to the liver and selectively acts to activate a thyroid hormone receptor, THR-β. This is underexpressed in patients with NASH. Clinical trials for this groundbreaking medication were performed at multiple ENCORE Research Group member sites, including Jacksonville Center for Clinical Research, Nature Coast Clinical Research, and St. Johns Center for Clinical Research. Trials remain ongoing throughout the country and we are excited to see resmetirom continue through the clinical trials process.

Watch a news interview about it here:

Jacksonville Center for Clinical Research is Participating in ORCA-3, a Phase 3 Clinical Research Study Evaluating an Investigational Smoking Cessation Therapy

Jacksonville Center for Clinical Research is enrolling eligible volunteers into ORCA-3, a U.S. Phase 3 clinical research study evaluating the safety and efficacy of cytisinicline, an investigational therapy for smoking cessation in adults who smoke ten or more cigarettes per day, intend to quit smoking and have failed at least one previous attempt to stop smoking with or without therapeutic support.

A recent report showed, in 2020, for the first time in twenty years, there was an increase in cigarette purchases[1]. Despite the clearly defined health risks associated with cigarette smoking, it is estimated that there are 34 million adults who are current cigarette smokers.[2] Prescription medication and counseling have been shown to improve quit rates yet are used by a minority of those trying to quit. Among the 68% of smokers who want to quit, less than 7% reported using counseling and only 29% reported using pharmacotherapy, and less than 5% used both.^[3]

Cytisinicline is a plant-based, naturally-occurring investigational compound that is structurally similar to nicotine and is believed to aid in smoking cessation by binding more specifically to a certain nicotinic receptor in the brain. This binding partially stimulates dopamine release, which reduces nicotine cravings and the severity of nicotine withdrawal symptoms. It also directly inhibits nicotine binding, reducing the satisfaction typically associated with smoking.

The FDA-approved non-nicotinic smoking cessation therapies, varenicline and bupropion, can improve rates of smoking cessation, but they are associated with troublesome side effects. Additional treatment options are needed if we are to help more people successfully quit smoking and reduce their smoking-related health risks. While the benefits of quitting cigarette smoking are well understood in both the medical and consumer communities, it is encouraged that cigarette smokers make quitting a resolution for 2022 and to speak with their health care providers about options that can help them succeed, including potential clinical trial participation when appropriate.

ORCA-3 is being conducted to learn more about the effectiveness and safety of 3.0 mg cytisinicline for 6 and 12 week study treatment periods in combination with behavioral support in people trying to quit cigarette smoking. The research will also assess the safety and tolerability of the study drug.

Jacksonville Center for Clinical Research is a clinical site participating in ORCA-3. The study is open to adults at least 18 years of age who currently smoke ten or more cigarettes per day, intend to quit smoking, and have failed at least one previous attempt to stop smoking with or without therapeutic support. Participants must be willing to set a quit date within 5-7 days of starting treatment and be willing to actively participate in the study’s smoking cessation behavioral support provided throughout the study.

If you or someone you know is interested in joining the study, please call 904-730-0166

[1] Cigarette Report for 2020 – ftc.gov. (n.d.). Retrieved November 9, 2021, from https://www.ftc.gov/system/files/documents/reports/federal-trade-commission-cigarette-report-2020-smokeless-tobacco-report-2020/p114508fy20cigarettereport.pdf.

[2] Centers for Disease Control and Prevention. Current Cigarette Smoking Among Adults in the United States. Available at: https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm. Updated November 18, 2019.

[3] Adams AJ and Hudmon KS. Pharmacist prescriptive authority for smoking cessation medications in the United States. J Am Pharm Assoc. 2018;58(3):253-257. doi: 10.1016/j.japh.2017.12.015

Jacksonville Cardiologist and JCCR Founder, Dr. Michael Koren M.D., published as first author an article in the prestigious journal Nature Medicine about a new, first-in-class Lp(a) lowering therapy called Olpasiran. Lp(a) is the lipoprotein that includes an LDL particle and the apolipoprotein a (protein portion that surrounds the LDL molecule) called LPA. Olpasiran prevents the LPA gene from forming apolipoprotein a; therefore, Lp(a) is not made.

Lipoprotein a, Lp(a), is an independent risk for cardiovascular disease. It is associated with a higher risk of heart attack or stroke and is pro-inflammatory. There are currently no pharmacotherapies directly targeting Lp(a) available for clinical use.

Still confused? Go to https://www.nature.com/articles/s41591-021-01634-w for more details on this exciting breakthrough.

(Images from FH Foundation)

First FDA Approved Therapy for Presbyopia (Age-Related Blurry Near Vision)

Vuity is the first FDA-approved therapy for presbyopia, and ENCORE Research Group helped make it a success.

12/1/21- Jacksonville, FL- Nature Coast Clinical Research Crystal River (NCCR-CR), a part of ENCORE Research Group, hosted clinical trials that led to the FDA approval of VUITY™. VUITY is the first FDA-approved therapy to treat presbyopia.

“The FDA approval of VUITY™ is so important because it treats a very common condition for anyone who is reaching 40,” Nina Smith, site manager at NCCR-CR. “We are happy to be a part of such a successful trial!”

Many adults find themselves using reading glasses, holding text further away, and increasing the font size and brightness on screens due to presbyopia. Presbyopia shows its signs nearing the age of 40 and affects over 128 million adults in the United States.

VUITY is a once-daily eye drop prescription that works as early as 15 minutes and lasts up to 6 hours. Clinical trials have shown that it improves near-sighted vision without impacting distance vision. VUITY’s success rate prompted other clinical trials as well to treat presbyopia. ENCORE Research Group is enrolling in new VUITY studies to test the product further. See the details below for more information on participation.

ENCORE Research Group is a premier clinical research organization with multiple research offices in Florida; three are located in Jacksonville. ENCORE Research Group sites have conducted more than 2,500 clinical trials over 24 years and have worldwide recognition for providing patients access to cutting-edge medical research.

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People interested in participating in a clinical research trial can visit encoredocs.com or call our headquarters office at (904) 730-0166

Contact: Sharon Smith

Phone: 904-730-1066

Email: ssmith@encoredocs.com

First Messenger RNA, RSV Vaccine Patient Dosed in Jacksonville, Florida

The first patient in a phase 2 study in the United States received a new, investigational Respiratory Syncytial Virus (RSV) vaccine in Jacksonville Center for Clinical Research.

11/17/2021- Jacksonville, Fl – Jacksonville Center for Clinical Research, a member of ENCORE Research Group, became the first in the United States to dose a new, investigational, Messenger RNA (mRNA), RSV vaccine to a patient in a phase 2 trial sponsored by Moderna, Inc. This helps the U.S. become closer to finding a preventative vaccine for RSV. RSV commonly has symptoms similar to influenza, COVID, and other highly pathogenic viruses.

“It is exciting to be a part of history,” Amber DeVries, study coordinator for the trial, says. “More than anything, though, it is an important step toward finding a vaccine for a virus that can be deadly.”

RSV infection rate has been on the rise, with cases skyrocketing in the summer of 2021. The cases were increasing so rapidly that the CDC issued a Health Alert on June 10, 2021. RSV is a virus that mainly affects children and adults over 65. RSV may cause severe complications to immunocompromised people.

“We should talk about and protect ourselves from the dangers of RSV,” Dr. Michael Koren, CEO of ENCORE Research Group, says. “COVID has captured our focus and rightfully so, but RSV cases have risen and continue to increase. Teamwork from the ENCORE Research Group, Moderna, and the clinical trial participants, has brought us one step closer to eradicating this virus.”

The RSV vaccine uses the same mRNA technology as the breakthrough COVID vaccines. The mRNA technology provides real-time instructions to make the proteins necessary to help our immune system fight off RSV. Many physicians and scientists believe mRNA has significant potential to improve patients’ lives.

People interested in participating in a clinical research trial can visit encoredocs.com or call our headquarters office at (904) 730-0166

Contact: Sharon Smith

Phone: 904-730-1066

Email: ssmith@encoredocs.com

We are excited to announce that we have moved our St. John’s office to a larger office space. We are now located at 100 Whetstone Place, Suites 300 – 301, St. Augustine, FL 32086. The office building is at the corner of 312 and Sargent Tutten Drive. Our phone and fax numbers are the same. Phone: 904-209-0043 Fax: 904-209-0047.

We are proud to announce that the US Food and Drug Administration (FDA) has approved lumasiran (now called OXLUMO™) for the treatment of primary hyperoxaluria type 1 (PH1). PH1 is a rare disorder that affects the kidneys causing severe pain in both children and adults.

ENCORE Research Group played a significant role in the clinical development of OXLUMO™ and we could not be prouder of all of our staff. However, none of this would be possible without the commitment and heroism of our patients who dedicated their time to improve medicine.

We asked, “What motivates you to participate in clinical trials?” With over 160 responses, the answer is clear. People who participate in clinical trials are dedicated to helping others by improving medicine for future generations.

We also found that very few were participating in order to receive the stipend for time and travel. This says a lot about the type of people who are willing to participate in clinical trials. They are in it for the cutting edge treatment, and the need to help others.

There is truly only one way to improve healthcare, and that is to participate in clinical trials. Thank you to everyone who responded to our survey, and everyone who participates in these trials.

We are excited to announce another FDA approved drug that was tested at ENCORE Research Group’s Nature Coast Clinical Research office In Crystal River Florida. Upneeq™, is a drug to help adults with blepharoptosis, or ptosis, which is a condition where there is an abnormal drooping of the upper eyelid causing a loss in vision. Upneeq™ is currently the only FDA approved medical treatment for drooping eyelids (ptosis).

For more information about this, view the full press release here:

https://www.osmotica.com/

To our ENCORE Community and Industry Partners,

ENCORE is taking the COVID-19 crisis seriously, in part by understanding that clinical trials will provide the only durable solution to this crisis and other afflictions facing our community and country.

All of our ENCORE sites are open for business for both patient and industry visits. We have added precautions to minimize the risk of virus transmission to patients and employees and to ensure that ongoing clinical trials are completed.

We have instituted more frequent and aggressive cleaning and infection control procedures. We also ask anyone with acute influenza-like symptoms or those who have been in close contact with individuals that have tested positive for COVID-19 to reschedule after following the federal guidelines for 14-day self-isolation. In taking sensible precautions, we hope our patients and industry partners will feel comfortable that our ongoing operations don’t put our community at risk…only benefit it.

We do understand some of our industry partners have implemented additional requirements for their staff and we are prepared to accommodate them remotely or virtually in order to keep projects moving forward.

Analysis of Clinicaltrials.gov shows there are nearly 80 clinical trials worldwide for investigational new treatments and vaccines in development. About 15 of those have been expanded to take place in the United States, of which, we aim to take part.

Sincerely,

Michael Koren, MD, FACC, FAPCR, CPI Medical Director and Chief Executive Officer

JACKSONVILLE, FL – ENCORE Research Group (ERG) and Borland Groover Clinic (BGC) announced today a clinical research joint venture. Effective March 1, 2019, Borland Groover Division of Research and Jacksonville Center for Clinical Research join forces under the newly organized entity, ENCORE Borland Groover Clinical Research (EBGCR). EBGCR will participate with seven other sites in Florida under the ENCORE umbrella. The partnership will bring the best of gastroenterology care and clinical research together with the goal of maximizing clinical trial opportunities for community patients and sponsors.

“EBGCR represents a terrific opportunity for physicians within and across specialties to cooperate on world class clinical research. We believe that the new joint venture will facilitate access to trials for appropriate patients and qualified physicians” according to Dr. Michael Koren, CEO of ENCORE Research Group.

Dr. Kyle Etzkorn, CEO of BGC said, “Borland Groover Clinic provides state of the art GI care. Our research joint venture with ENCORE enables us to more broadly apply our knowledge and technology to clinical research development programs”.

The clinical research industry has become more challenging in recent years for a variety of reasons including greater regulatory scrutiny, increasing complexity of trials and the unpredictability
of the duration and success of individual projects. As Florida’s leading health providers, BGC and ERG strive to deliver easy access to the high potential, advanced, and innovative treatments offered in clinical trials.

For more information contact Cynthia Buda, RN, CCRC, EBGCR Lead at cbuda@encoredocs.com.

About ENCORE

ENCORE Research Group currently conducts research at seven locations in the State of Florida. Sites include Fleming Island Center for Clinical Research, Jacksonville Center for Clinical Research, Nature Coast Clinical Research – Crystal River, Nature Coast Clinical Research – Inverness, River City Clinical Research, St. Johns Center for Clinical Research and Westside Center for Clinical Research. In addition, ERG has established an information technology division that conducts research training, develops software products for clinical trialists and serves as an incubator for web-based IT products that link physicians and their patients.

About Borland Groover Clinic

Over the past 70 years, Borland Groover has grown into one of Florida’s largest gastroenterology practices with more specialists, more locations and more hospital partnerships to deliver the most advanced treatments and the best possible patient care. BGC physicians provide care for more than 100,000 patients each year with digestive disorders and conditions that include inflammatory bowel disease, liver disease including hepatitis, irritable bowel syndrome, acid reflux disease, esophageal disorders and more. BGC physicians perform more than 50,000 colonoscopies a year, the only procedure used effectively for colon cancer prevention, and for diagnosing colonic disease.

Name of Press Contact: Cynthia Buda
Date: 08 Feb 2019
Phone: 904-621-0390
Email: cbuda@encoredocs.com

Register to attend our 17th annual Clinical Research Training for Physicians! This TransCelerate GCP approved course will earn you CME credits while exploring the ethical, legal, and medical nuances of being an investigator in clinical trials. The course takes place November 2nd and 3rd 2018 at the University of North Florida in Jacksonville, Florida. Visit investigatortraining.info for details on speakers, agenda, and registration.

ENCORE, now a nationally recognized research group, proudly announces the launching of the ENCORE Lipid Center of Excellence. ENCORE stands for ENcouraging COmmunity Research and Education. Our new Lipid Center extends our previous successes in this important area of public health. Lipid problems account for a huge number of heart attacks, strokes and other vascular disease problems each year.

ENCORE CEO and Founder, Dr. Michael Koren, a cardiologist and renown researcher in the area of lipids, has had a long standing interest the treatment of challenging lipid disorders. He will be leading the Center along with Lori Alexander, a Clinical Lipid Specialist and researcher who is very active with the National Lipid Association. They both have been a part of ENCORE Research since its formation, and will be putting together resources to bring new lipid treatment studies to the Center. Previous successes have involved major contributions in widely prescribed cholesterol drugs such as Lipitor and Crestor.

There are many exciting new medications currently being developed to treat conditions such as elevated lipoprotein (a), an important risk factor for heart disease, which will be conducted at the Lipid Center of Excellence. These studies can offer an opportunity for the community to access cutting-edge treatments. Join your fellow community members who have already derived educational and health awareness benefits from their participation in research studies. Donna Toy, a wonderful, longstanding patient who has suffered many family losses from severe cholesterol problems may have said it best: “I have such peace of mind knowing that we can be helped in controlling our heart disease and learn more about our conditions with hands-on help.”

Patients can contact Sharon Smith at 904-730-0166 or Lori Alexander, Director at 904-730-0101 for more information on the Lipid Center of Excellence. Sponsors can contact Jolenne Wolfer 904-732-6683 jwolfer@encoredocs.com.

Jacksonville Center for Clinical Research (JCCR) University site has conducted over 1,000 clinical trials since 1997. Our four acre campus also houses the corporate offices for centralized site services for Encore Research Group (Our network of sites in the state of Florida). The impressive investigator panel includes more than 50 physicians conducting trials in 25 therapeutic areas. JCCR is well equipped to perform Phase 1 through Phase 4 studies, including first-in-human PK and PD protocols. Enhanced capabilities of our site include long-term stay facilities, and treadmill equipment, and an active inpatient trial team.

Management

Michael J. Koren, MD, FACC, CPI – Chief Executive Officer
Richard Smith, RN – Lead Coordinator

Facility Description

Multiple Bedrooms
Treadmill & Cardiorespiratory diagnostic capabilities room
Private bath with shower
1 mile to emergency room
Full kitchen

GRID VIEW

FDA Approves Lilly’s Kisunla for Alzheimer’s Disease

ENCORE Research Group Merges with Flourish Research

FDA Approves Moderna RSV Vaccine for Older Adults

FDA Approves Rezdiffra, First NASH Treatment In The United States

Oral PCSK9 Inhibitor Redefines Cholesterol Control

FDA Approves Valneva’s IXCHIQ, World’s First Chikungunya Vaccine

FDA Approves Phathom Pharmaceuticals’ VOQUEZNA for healing treatment of erosive GERD

FDA Approves Pfizer’s RSV Vaccine For Older Adults

FDA Approves Lexicon’s INPEFA (sotagliflozin) Daily Pill For treatment of Heart Failure

FDA Approves AbbVie’s RINVOQ daily pill for Crohn’s disease

FDA Approves Astellas’ VEZOAH, the First Non-Hormonal Treatment for Menopause-Related Vasomotor Symptoms

FDA Approves GSK’s Arexvy, the First RSV Vaccine for Adults Over 60

FDA Approves Preventative Medication for Recurrent C. difficile Infection

Lowering RSV incidence with a promising vaccine

Vibrating Capsule ‘Vibrant’ Cleared by FDA as a New Drug-Free Treatment for Constipation

Olpasiran: A Promising New Investigational Drug for Lipoprotein (a) Treatment

ENCORE Research Group: A Leader in Clinical Research with Three ACRP Certified Principal Investigators

Celebrating 26 Years of Service to the Florida Community!

Listen to the article here:

Nature Coast Clinical Research Announces the Remodeling of Its Inverness, Florida Office, Now Offering Phase 1 Clinical Trial Capabilities

Madrigal announces positive headline results for Resmetirom

Watch a news interview about it here:

Jacksonville Center for Clinical Research is Participating in ORCA-3, a Phase 3 Clinical Research Study Evaluating an Investigational Smoking Cessation Therapy

Ever wonder how medical breakthroughs occur and become known?

First FDA Approved Therapy for Presbyopia (Age Related Blurry Near Vision)

First Messenger RNA, RSV Vaccine Patient Dosed in Jacksonville, Florida

Our St. John’s Office Has Moved to St. Augustine

New Drug FDA approved lumasiran (OXLUMO™) for Hyperoxaluria

The Research of Research

Ptosis drug FDA Approved

COVID-19 Update

Northeast Florida Gastroenterology Medical Research Sites Combine to Bring Greater Value to Patients and Sponsors

ENCORE Clinical Research Training for Physicians – not your typical GCP course!

Lipid Center of Excellence

Phase 1 Capabilities

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