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RedHill Biopharma has submitted an application to Mexico’s COFEPRIS and initiated a filing with Brazil’s ANVISA to conduct a Phase II/III clinical trial of opaganib (Yeliva, ABC294640) in hospitalised patients with severe Covid-19 pneumonia.
Applications for this trial have already been approved in the UK and Russia. A separate application is under review by Italian regulatory agency, with plans to expand to other countries.
Opaganib is an oral selective inhibitor of sphingosine kinase-2 (SK2) that is said to exhibit anti-cancer, anti-inflammatory and anti-viral activities. Inhibition of SK2 effects various cellular pathways involved in cancer growth, viral replication, and pathological inflammation.
The multi-centre, randomised, double-blind, parallel-arm, placebo-controlled Phase II/III trial will enrol up to 270 severe Covid-19 pneumonia patients who require hospitalisation and treatment with supplemental oxygen.
Participants will be given opaganib or placebo, along with standard of care therapy. The trial’s primary endpoint is the proportion of patients who need incubation and mechanical ventilation by day 14.
An independent data safety monitoring board (DSMB) will perform interim futility analysis after approximately 100 patients have been assessed for the primary endpoint.
RedHill Biopharma Clinical Affairs vice-president Aida Bibliowicz said: “We are advancing rapidly with our Phase II/III programme for Covid-19 and continue to expand the study to additional countries where there is substantial growth in diagnosed cases.
“In parallel, good progress has been made with the ongoing Phase II study with opaganib in the US. If successful, our goal is for the compiled clinical data set to support potential applications for emergency use authorisation in the fourth quarter of this year.”
The randomised, double-blind, placebo-controlled Phase II trial of opaganib in the US is currently enrolling participants, with a target of up to 40 severe Covid-19 pneumonia patients who need hospitalisation and supplemental oxygen by the end of next month.
The company recently reported findings from the analysis of treatment outcomes in five patients with severe Covid-19, where the drug showed substantial benefit to patients in clinical outcomes and inflammatory markers.