Relief Therapeutics has announced that its NeuroRX-partnered COVID-19 drug RLF-100 met the survival threshold in intensive care patients and added that it expects detailed trial data this year.
Relief and NeuroRx are still awaiting the detailed results from rigorous randomised studies of RLF-100 (aviptadil) for the treatment of COVID-19 patients.
However, in top-line results from an open-label prospective study of patients who had severe comorbidities that meant they were ineligible for the ongoing controlled phase 2/3b trial, RLF-100 appeared to possess efficacy against COVID-19.
The companies said that 81% of patients treated with RLF-100 survived beyond 60 days, compared to 17% of patients who did not receive the medication.
In addition, patients treated with RLF-100 demonstrated a nine-fold increased possibility of survival and recovery from respiratory failure, along with a high degree of statistical significance.
“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 Jonathan Javitt, chief executive officer and chairman of NeuroRx.
“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 [in the study] is modest, the initial results in our nationwide expanded access programme suggest similarly encouraging survival with RLF-100. We continue to closely monitor treatment with RLT-100T in other hospitals,” he added
RLF-100 is a formulation of vasoactive intestinal polypeptide (VIP) that was originally awarded a US Food and Drug Administration (FDA) orphan drug designation in 2001.
VIP is known to be highly concentrated in the lungs and thought to block the formulation of inflammatory cytokine and prevent cell death.
The FDA has now granted the drug an investigational new drug (IND) authorisation and a fast track designation for intravenous and inhaled delivery for the treatment of COVID-19.
The potential COVID-19 treatment is being investigated in two controlled phase 2/3b clinical trials in respiratory deficiency caused by COVID-19.