NeuroRx, Inc., in partnership with RELIEF THERAPEUTICS Holdings AG today announced that the independent Data Monitoring Committee has reviewed the findings in the first 30 patients treated in Fast Track FDA trials of RLF-100 (Aviptadil) in patients with Critical COVID-19 with respiratory failure.
The study protocol enrolls patients with Critical COVID-19 and Respiratory Failure and randomly assigns them to intravenous RLF-100 or Placebo in the hopes of achieving remission from this most-serious stage of COVID-19. At the committee’s recommendation, the primary endpoint is changed to “alive and free of respiratory failure at 7-10 days.” This change in primary endpoint from mortality at 28 days is driven by the general decrease in mortality with advances in treatment for Critical COVID-19 and by initial observations in the clinical trial.
This first interim analysis was focused on verifying the apparent safety of the drug in the first 30 patients and the feasibility of the study to reach its endpoint. The committee determined that the study appeared capable of reaching a statistically significant endpoint within its 144 patient sample size and voted for the study to continue until its next scheduled evaluation in four weeks.
The committee is composed of Prof. Alfred Sommer, MD, MHS, Dean Emeritus of the Johns Hopkins Bloomberg School of Public Health, Prof. Rita Colwell, PhD, former Director of the National Science Foundation, and Congressman Andy Harris, MD, MHS (MD District 1) a part time Professor of Anesthesia and Critical Care at Johns Hopkins School of Medicine.
RLF-100 (Aviptadil) received Fast Track designation from the US FDA for the treatment of Critical COVID-19 with respiratory failure. RLF-100 is a synthetic form of human Vasoactive Intestinal Peptide (VIP) which is known to protect the Alveolar Type II cell of the lung from many forms of injury. This cell is critical to transmission of oxygen to the blood and is the site of attack for the Coronavirus.
“This milestone represents the extraordinary effort of our partners and collaborators at the University of Miami, Houston Methodist Hospital, UC Irvine, and the University of Louisville who gave 100% to providing patients with Critical COVID-19 a chance to benefit from a potentially life-saving drug. We thank the members of the Data Monitoring Committee for devoting their valuable time to performing this vital role in helping to evaluate the safety and effectiveness of RLF-100,” said Prof. Jonathan C Javitt, MD, MPH, CEO of NeuroRx and the National Study Chair.
Details of the study are posted on clinicaltrials.gov NCT04311697.
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