East Coast Institute for Research, a clinical investigational site in Jacksonville, Florida, will commence a novel clinical trial next week testing Regeneron’s REGN-COV2, the monoclonal antibody designed to target SARS-COV-2. The study will be led by Dr. Rebecca Goldfaden, vice president of Clinical Operations. In this accelerated Phase 3 study, the research site seeks participants who have been exposed to COVID-19 via a housemate or family member.
TrialSite commenced tracking this soon to be launched study sponsored by Regeneron. Testing a cocktail of two monoclonal antibodies, the study seeks those who have had someone in their home tested positive for COVID-19 in the last 96 hours. This promising treatment made its way to Phase 3 in an accelerated manner, as recently discussed by TrialSite.
Dr. Goldfaden explained that this isn’t a vaccine and noted, “The purpose of this study is looking to prevent those high-risk individuals who have been exposed from getting the COVID-19 disease, or if they have already been exposed to prevent the symptomatic disease.”
Patients who are part of the study, after giving verbal consent, will receive a full physical exam, lab work, COVID-19 testing, and an injection of monoclonal antibodies. Goldfaden notes, “This study is looking at a one-time dose. It’s a subcutaneous injection, so a very small injection right underneath the skin, one time.” She said the shot will be administered in the lower abdomen, upper legs, or upper arms. “The main side effects associated with monoclonal antibodies is pain at the injection site,” Goldfaden commented. “As part of the clinical study, we are looking to see if there are additional side effects.” Goldfaden said participants who qualify will be reimbursed for their time and travel.
The Investigational Product
A recent report authored by Regeneron et al. shows that neutralizing antibodies are increasingly considered a valuable approach to treating infectious diseases. The authors introduce a purported recent success story focusing on antibody treatments for Ebola sourced from 1) genetically-humanized mice and 2) a human survivor. Hence, Regeneron took this concept and ran with it, leveraging Regeneron’s proprietary development platform, developing a similar treatment, that is antibodies against the SARS-CoV-2 spike protein originating from both 1) humanized mice and 2) convalescent patients.
This yielded a large collection of fully-human antibodies that were thereafter characterized for binding, neutralization, and three-dimensional structure. Summarizing what is undoubtedly far more complex, Regeneron and research partners identified a part of “highly-potent individual antibodies that simultaneously bind the receptor-binding domain of the spike protein, providing ideal partners for a therapeutic antibody cocktail that aims to decrease the potential for virus escape mutants that might arise in response to selective pressure from a single antibody treatment.”
Regeneron was able to secure rapid regulatory approval to launch clinical trials based on the antiviral antibody cocktail. Initiating what they reported were the first Phase 1/2 clinical trials combining the monoclonal antibodies called REGN10933 and REGEN10987, collectively known as REGN-CoV2, first in ambulatory and hospitalized adult patients who tested positive for COVID-19. According to Regeneron, those studies would retrospectively investigate and compare the two-drug combination versus placebo in 1,052 and 1,086 patients.
The Site Profile: East Coast Institute for Research
East Coast Institute for Research is dedicated to developing ground-breaking new research to benefit the community. Seeking to conduct studies with the latest investigational therapies and medications, ECIR has state-of-the-art facilities in Northeast Florida and Georgia. The research site showcases existing and past client sponsors and include some of the largest and most prominent pharmaceutical companies such as Merck, Bayer, Novo Nordisk, Amgen, Gilead, and GSK. The firm employs about 25.
The site was founded over ten years ago by Rushab Choksi, PharmD, with the vision of completing Phase II-IV clinical trials in the private practice physician network. He worked for pharmaceutical companies prior to launching this site and, in the process, developed a strong background in medical affairs involving multiple product launches. His therapeutic expertise spans a broad range of disease states from cardiology, endocrinology, nephrology, pulmonary medicine, and primary care.
While Rebecca Goldfaden PharmD, CCRP, serves as vice president of clinical operations.
Call to Action: If you are based in the Jacksonville area and meet the inclusion criteria, consider connecting with this study site. They are located at the clinic across from Memorial Hospital on University Blvd. in Jacksonville, Florida.