RedHill Biopharma has reported two prespecified analyses results from Phase II/III clinical trial of oral opaganib (ABC294640) in severe Covid-19 patients admitted to the hospital.
An oral, novel chemical entity, opaganib is a selective inhibitor of sphingosine kinase-2 (SK2).
According to the first analysis data from the trial, opaganib substantially lowered mortality when administered to study subjects following remdesivir and corticosteroids, which are claimed to be the best available standard-of-care (SoC) for hospitalised patients.
The prespecified mortality analysis of subjects who were given remdesivir and corticosteroids at baseline, a 70.2% mortality benefit was observed in patients treated with opaganib.
By day 42, 6.98% and 23.4% mortality rate were observed in the opaganib plus SoC group and placebo plus SoC group, respectively.
In the second prespecified analysis, opaganib offered a 34% benefit in time to recovery, as defined by attaining a score of one or less on the WHO Ordinal Scale by day 14.
Furthermore, 37.4% of subjects in the opaganib arm attained this benefit compared with 27.9% in the placebo plus SoC arm.
Data submissions on opaganib commenced in the fourth quarter of last year in the US, Europe, the UK and other countries.
Initial guidance with regard to a confirmatory trial and the possible path to approval was provided by the European Medicines Agency, US Food and Drug Administration and UK Medicines and Healthcare products Regulatory Agency among others.
RedHill is in talks with regulatory agencies in various countries, with plans to file emergency and marketing authorisation applications in some countries in the first half of this year.
RedHill chief scientific officer Dr Mark Levitt said: “These prespecified analyses, along with the recent data showing opaganib’s improved median time to viral RNA clearance, provide strong support for the promising results observed in Phase II/III study post-hoc analysis.
“Oral opaganib has now shown an ability to reduce deaths, speed up recovery and clear viral RNA, all with a safety and tolerability profile similar to placebo. Strikingly, opaganib has delivered these benefits over and above the very best level of current standard-of-care, with patients receiving both remdesivir and corticosteroids.”
In October last year, the company reported latest results from the global Phase II/III trial of oral drug opaganib in hospitalised patients with severe Covid-19 pneumonia.