Specialty biopharmaceutical company RedHill Biopharma is set to expand its global Phase II/III study of opaganib in patients with severe Covid-19 to the US.
A novel, orally administered sphingosine kinase-2 (SK2) inhibitor, opaganib has shown antiviral, anti-inflammatory and anti-thrombotic activity and targets a human cell component involved in viral replication.
The latest move comes after the US Food and Drug Administration (FDA) reviewed the data from the US Phase II study of opaganib and issued recommendations.
RedHill noted that the expansion to the US will cause alterations to the trial protocol based on the FDA’s recommendations and ongoing talks.
The new development will aid in expediting enrolment, expanding the study to eight countries and around 40 recruiting sites, with more sites and countries on the cards.
So far, the study on 464 subjects is 50% enrolled and is anticipated to provide top-line data in the second quarter of this year.
Previously, the global Phase II/III study had undergone a DSMB futility review, which indicated that it can potentially provide a positive outcome.
Phase II data also showed no material safety differences between the opaganib and placebo treatment arms, further adding to the growing safety database for opaganib.
Recently, RedHill reported that safety and efficacy data from a non-powered US Phase II study of opaganib in patients with Covid-19 pneumonia showed greater improvement in lowering oxygen needs by end of treatment on day 14 across primary and secondary efficacy outcomes.
Furthermore, the data showed no material safety differences between opaganib and placebo treatment groups.
Last July, RedHill Biopharma 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 in hospitalised patients with severe Covid-19 pneumonia.