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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.