RedHill Biopharma has concluded enrolment in the global Phase II/III study of oral drug opaganib (Yeliva, ABC294640) in hospitalised patients with severe Covid-19 pneumonia.
A chemical entity, opaganib is designed to selectively inhibit sphingosine kinase-2 (SK2) and has anti-inflammatory and antiviral properties.
The trial enrolled and randomised a total of 475 subjects, slightly higher than the originally planned 464 participants.
The proportion of subjects breathing without needing oxygen support by day 14 is the trial’s primary goal.
Furthermore, the trial will analyse other key outcome measures in the follow-up period of up to six weeks. These measures include time to hospital discharge, health progress measured as per the World Health Organization Ordinal Scale for Clinical Improvement and intubation and death.
Promising data has so far been observed in an analysis of the blinded blended intubation and mortality rates versus reported mortality rates from large platform trials, including RECOVERY and other trials in similar subjects.
On reviewing unblinded safety and futility data, four independent data and safety monitoring board (DSMB) recommendations were provided to advance the trial.
Redhill Biopharma medical director Mark Levitt said: “Enrolment completion of this 475-patient global study of oral opaganib for Covid-19 is a truly exciting milestone in the urgent search for an effective pill to treat Covid-19, positioning opaganib as a leading novel, dual-action, investigational Covid-19 oral treatment.
“Acting on the cause and effect of Covid-19 through a dual antiviral and anti-inflammatory effect, opaganib is host-targeted and is therefore expected to be effective against emerging viral variants.”
Apart from current discussions with the US Food and Drug Administration and various other regulators, Redhill held talks with the European Medical Agency on the drug’s European pathway.
Separately, AzurRx BioPharma dosed the first subject in Phase II RESERVOIR clinical trial of its tablet formulation of micronized niclosamide, FW-1022, for treating Covid-19-linked gastrointestinal infections.
The company expects to report top-line results from the trial in the first quarter of next year.