Subjects in the trial received either opaganib or placebo.. Credit: HeungSoon from Pixabay.

RedHill Biopharma has reported new data from the global Phase II/III clinical trial of oral drug opaganib (ABC294640) conducted in patients hospitalised with severe Covid-19 pneumonia.

The latest move follows the completion of enrolment of 475 people for the multi-centre, randomised, double-blind, parallel-arm, placebo-controlled global trail in June this year.

Opaganib is designed to selectively inhibit sphingosine kinase-2 (SK2) and has anti-inflammatory and antiviral properties.

Subjects in the study were randomised at a 1:1 ratio and given either opaganib or placebo on top of the standard-of-care therapy they received.

The new data demonstrated a 62% statistically significant reduction in mortality for moderately severe Covid-19 patients group treated with opaganib versus the placebo-controlled arm.

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It also demonstrated a statistically significant efficacy benefit of 21% using opaganib in reaching room air by Day 14, which forms the primary endpoint of the trial.

RedHill stated that the clinical trial data has further shown a median of four days earlier hospital discharge for patients treated with the drug compared to those who received placebo.

This represented a cumulative saving of 524 days of hospitalisation across the patient group by Day 42.

RedHill medical director Mark Levitt said: “These new findings support the potential for opaganib’s use in hospitalised, moderately severe Covid-19 patients, a key group of patients that are at high risk of disease progression, morbidity and mortality, and who may benefit from opaganib’s combined antiviral and anti-inflammatory activities.

“The results provide a strong rationale for opaganib’s potential efficacy in hospitalized patients in need of oxygen supplementation up to 60% FiO2, a large proportion of hospitalised Covid-19 patients.

“The Phase II/III study results are also consistent with opaganib’s earlier US Phase II study results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants in human bronchial epithelial cells, providing further support for its potential in earlier stages of disease where viral load is higher.”