RELIEF THERAPEUTICS Holding AG with its partner NeuroRx, Inc., has announced, 150 patients (out of a targeted enrollment of 165) have been enrolled in the ongoing phase 2b/3 trial of RLF-100™ (aviptadil) for treating respiratory failure in patients with critical COVID-19. Respiratory failure is defined, according to FDA guidance, 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. So far, no drug-related serious adverse events have been reported.
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. Although NeuroRx and Relief are optimistic that RLF-100™ will also be effective in treating early COVID-19, the companies have focused first on those patients who have no available therapy and are at the highest risk of mortality. An open-label prospective study in patients with Critical COVID-19 has already shown a nine-fold hazard ratio advantage in both survival and recovery from respiratory failure with both statistically significant (P < .001). More than 110 patients with similar severity have additionally been treated nationwide under an FDA-sanctioned Expanded Access Protocol.
Although the phase 2b/3 study remains blinded, illustrative blinded recoveries from signs of Critical COVID-19 on Chest x-ray within 10 days have been reported by study sites and shared with the study’s Data Monitoring Committee and FDA (see figure). Until the study is unblinded, it cannot be known whether this rapid recovery was more frequent among patients treated with RLF-100™ compared to those treated with placebo. However, in the open-label prospective study, more rapid recovery was seen among 21 patients treated with RLF-100TM than those treated with standard of care with an average of nine fewer ICU days in the RLF-100TM treated patients compared to those treated with Standard of Care.
Completion of enrollment is anticipated in the coming weeks. Enrollment was uniquely challenged by the devastating effects of the pandemic. It strained the capacity of hospitals and caused the temporary incapacity of investigators and study coordinators at several study sites, who themselves contracted COVID-19 in the course of their duties.
“Should RLF-100™ prove to be safe and effective for treating COVID-19 Respiratory Failure, the nation will owe an eternal debt of gratitude to the front-line healthcare workers, technicians, study coordinators, nurses, and doctors who worked seven days a week to help develop this treatment while risking their own health to do so. They are the true heroes,” said Prof. Jonathan Javitt, CEO and founder of NeuroRx, Inc.
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