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

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

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.