NeuroRx and Relief Therapeutics have announced that the independent Data Monitoring Committee (DMC) has voted for the continuation of the Phase IIb/III trial of RLF-100 (aviptadil) to treat respiratory failure in critically ill patients with Covid-19.
The committee identified no safety concerns and the trial will continue as planned to its full enrolment of 165 patients.
DMC also noted that the trial is capable of reaching its endpoint in proving that RLF-100 is superior to placebo in achieving recovery from respiratory failure in critical Covid-19 patients at a statistically significant level.
RLF-100 is a formulation of Vasoactive Intestinal Polypeptide (VIP), which is present in high concentrations in the lungs and is known to block various inflammatory cytokines.
In June, the US FDA granted fast track designation to RLF-100, which has also received orphan drug designation for the treatment of acute respiratory distress syndrome (ARDS).
The DMC review and approval is backed by data from 102 patients, who were randomly assigned to intravenous RLF-100 versus placebo and observed for 28 or more days.
The patients enrolled in the trial will include those hospitalised in intensive care units with respiratory failure who are treated by mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen.
To date, 133 patients have been treated and the trial intends to complete enrolment by mid-December and obtain top-line data in January next year.
The seven-member monitoring panel had two independent biostatisticians, an epidemiologist/clinical trials expert, a bioethicist, a public representative, and clinical experts in pulmonary and critical care medicine.
In August, NeuroRx and Relief Therapeutics have found that RLF-100 (aviptadil) led to rapid recovery from respiratory failure in critically ill patients with Covid-19.