Relief Therapeutics and NeuroRx announced topline efficacy data from patients treated with RLF-100 (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to critical COVID-19. The topline results are from 45 patients who were assessed, 21 of whom were admitted to an intensive care unit with respiratory failure and critical COVID-19. All patients exhibited comorbidities that left them ineligible for the ongoing randomized controlled Phase IIb/III trial to determine the safety and efficacy of RLF-100. Additionally, they all appeared to deteriorate, despite receiving approved therapies for COVID-19.
Overall, 81% of RLF-100-treated patients survived beyond 60 days, compared to 17% of control patients. Patients treated with RLF-100 demonstrated a 9-fold increased probability of survival and recovery from respiratory failure, with a high degree of statistical significance.
RLF-100 (Aviptadil) is a formulation of Vasoactive Intestinal Polypeptide (VIP). VIP is known to be highly concentrated in the lungs, where it inhibits coronavirus replication, blocks the formation of inflammatory cytokines, prevents cell death, and upregulates the production of surfactant. The FDA has now granted IND authorization for intravenous and inhaled delivery of RLF-100 for the treatment of COVID-19 and awarded Fast Track designation. RLF-100 is being investigated in two placebo-controlled US Phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Top-line data from the trials are expected this quarter.