Relief, NeuroRx to test aviptadil for treating respiratory failure in Covid-19 patientsDecember 7, 2020
|Relief Therapeutics and NeuroRx have met the 165 patient enrollment target agreed with the U.S. Food and Drug Administration (FDA) in the ongoing phase 2b/3 trial of RLF-100 (aviptadil) for treating Respiratory Failure in patients with Critical COVID-19. |
“Although enrollment has been uniquely challenged by the devastating effects of the pandemic, straining the capacity of hospitals and exposing our investigators and study coordinators to personal peril from COVID-19 in the course of their duties, we are proud to meet our enrollment target as planned,” said Prof. Jonathan Javitt, CEO and founder of NeuroRx, Inc. “Achieving this milestone in the midst of the pandemic has only been possible because of the extraordinary dedication of the doctors, nurses, pharmacists, and study coordinators who continued to work around the clock to develop this much-needed therapy.”
Respiratory Failure is defined, according to the FDA, as the need for intensive care with mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen in order to sustain adequate levels of blood oxygen.
There is currently no FDA-approved drug that has shown efficacy in patients who are already in the Intensive Care Unit (ICU) with Respiratory Failure, the companies noted in the press release.
In addition to the ongoing phase 2b/3 trial, more than 200 patients with Critical COVID-19 and respiratory failure have been treated in an FDA-approved, Expanded Access Protocol (EAP) for RLF-100™. These patients were unable to enter the phase 2b/3 randomized trial due to severe comorbidities (such as organ transplant, recent heart attack, or cancer).
While the companies have focused first on those patients who have no medical alternative and are at immediate risk of death, a phase 2b/3 trial with RLF-100™ for inhaled use in patients with moderate and severe COVID-19 in order to prevent progression to respiratory failure is expected to start soon.
Although the phase 2b/3 study will remain blinded until the final patients reach day 28, the companies said, unexpected rapid recovery on chest X-ray has been reported by study sites and frequently reported in the open-label Expanded Access Protocol as well. In the EAP, of the 90 patients who have reached 28 days post-treatment, 72% have survived to day 28. They said that the clinical trial will continue to enroll patients through the anticipated early Q1 2021 announcement of top line data in order to amass as large a safety database as possible. To date, no drug-related Serious Adverse Event has been reported in any of the ongoing studies of RLF-100™, which is consistent with the absence of toxicity seen in extensive nonclinical safety testing and prior human studies.