Speciality biopharmaceutical company RedHill Biopharma has reported positive results in the preliminary top-line data from the US Phase II study in patients hospitalised with Covid-19 pneumonia who had been orally administered opaganib (Yeliva, ABC294640).
A novel chemical entity, opaganib is a proprietary sphingosine kinase-2 (SK2) selective inhibitor.
It targets a human cell component linked to viral replication, possibly lowering the chances of resistance due to viral mutations.
The randomised, placebo-controlled, double-blind, proof-of-concept study of opaganib registered 40 patients needing oxygen support.
The US Phase II therapy study is designed to analyse safety and detect preliminary signs of activity.
Participants were randomly given either opaganib or placebo along with the standard of care (SoC) and were followed up for up to 42 days after starting treatment.
Preliminary results from the trial showed that opaganib was safe, with no material safety differences between opaganib and control groups.
Data showed that a consistent trend of better improvement in lowering oxygen needs at day 14 in the treatment arm was observed right through key primary and secondary efficacy outcomes.
Furthermore, 73.7% of patients in the treatment group were discharged by day 14 versus 55.6% in the control group.
RedHill medical director Mark Levitt said: “We are pleased with these encouraging top-line results from our exploratory Phase II study, which confirm opaganib’s safety and demonstrate promising signals of activity when treating patients with Covid-19, and who require oxygen support.
“These preliminary results support our ongoing global Phase II/III study in severe Covid-19 pneumonia, which is expected to read out in Q1/2021.”
The full analysis of the data from the trial is anticipated soon.
Last month, RedHill received a second unanimous DSMB recommendation to continue the global Phase II/III study of opaganib in patients hospitalised with severe Covid-19 pneumonia.
It is being carried out across 30 clinical sites in various countries and will enrol up to 270 patients.