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Wednesday, August 12, 2020 10:19:17 AM
On July 16, 2020, Relief Therapeutics and NeuroRx announced that the Data Monitoring Committee conducted a planned review of the first 30 patients treated in the Phase II/III Fast Track trial (Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure (COVID-AIV)). Per the release:
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.
This appears to be a tremendous vote of confidence from the Data Monitoring Committee. Not only did they recommend that the study continue, after only 30 patients they determined that statistical significance appears to be reachable within the 144 patients in the trial. According to Relief Therapeutics and NeuroRx, "[the] Data Monitoring Committee determined that so far RLF-100 has generated no drug-related Serious Adverse Events or other safety concerns that would mandate stopping."
Of note, the Data Monitoring Committee is composed of the following individuals: 1. Professor Alfred Sommer, MD, MHS, Dean Emeritus of the Johns Hopkins Bloomberg School of Public Health; 2. Professor Rita Colwell, PhD, former Director of the National Science Foundation; and 3. Congressman Andy Harris, MD, MHS (MD District 1), also part-time Professor of Anesthesia and Critical Care at Johns Hopkins School of Medicine.
Coming Data Points
Based upon the companies' July 16 release, the DMC will evaluate the patient data in the Phase II/III Critical patient study again "in four weeks," which puts the next possible data release on about August 13, Thursday of this week.
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