Relief Therapeutics and NeuroRx released results on Tuesday from their open-label prospective study looking into RLF-100 (aviptadil) as a potential treatment for COVID-19 and respiratory failure.
The topline results came 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 the disease.
Overall, approximately 81% of the patients who received RLF-100 survived beyond 60 days, compared to just 17% of control patients. Those who had the treatment also demonstrated a nine-fold increased probability of survival and recovery from respiratory failure.
“We are encouraged by these initial results in highly comorbid patients with COVID-19 respiratory failure, and we are pleased that the majority of these patients have returned safely to their families. We look forward to the upcoming results from the randomized, double-blind, prospective trial in less severely comorbid patients for confirmation of these results,” said Jihad Georges Youssef, MD, section chief of General Academic Pulmonary Medicine at the Houston Methodist Hospital, who serves as the study’s principal investigator at Houston Methodist and also serves as national co-chair for the ongoing randomized controlled trial.
RLF-100 is a formulation of Vasoactive Intestinal Polypeptide (VIP). VIP is known to be highly concentrated in the lungs, where it prevents the replication of the coronavirus. It also blocks the formation of inflammatory cytokines, prevents cell death and upregulates the production of surfactant. The U.S. Food and Drug Administration has awarded RLF-100 Fast Track Designation.
“The patients included in this study are representative of those who are too ill to be included in the clinical trials of any known treatment for COVID-19,” said Dr. Jonathan Javitt, CEO and Chairman of NeuroRx, Inc. “We are grateful to Dr. Youssef and to the Houston Methodist Hospital for having the courage to treat and study patients at this level of risk. The results suggest that there may be substantial hope to mitigate the attack of the coronavirus on the delicate cells that line the lung with a natural peptide that has been protecting the lung’s lining since humans first walked the earth. While the number of patients treated at Houston Methodist is modest, the initial results in our nationwide expanded access program suggest similarly encouraging survival with RLF-100. We continue to closely monitor treatment with RLT-100 in other hospitals.”
NeuroRx and Relief Therapeutics announced back in September that they had established supply chain agreements and ordered sufficient amounts of RLF-100 to treat approximately one million patients with COVID-19. NeuroRx and Relief Therapeutics are leading U.S. and European Union commercialization plans, respectively. They have also entered a contract with Nephron Pharmaceuticals, Inc. to manufacture commercial supplies of RLF-100 to ensure that the drug supply is sustained and immediately available.
In addition, Bachem Americas has entered an agreement with the companies to manufacture RLF-100 to treat one million COVID-19 patients.
“In normal circumstances, it would be prudent to wait until all the data are in before initiating commercial scale-up,” said Javitt. “However, in an environment where more than 40,000 Americans are contracting COVID-19 daily and 800 are dying each day, there is not a moment to lose in ensuring that sufficient quantities of RLF-100 will be available, should the clinical trials succeed in proving safety and efficacy.”
