RedHill announces positive top-line data for COVID-19 pneumonia drug

pharmafile | January 4, 2021 | News story | Sales and Marketing COVID-19 

RedHill Biopharma has announced that preliminary top-line data from its US Phase II study with orally-administered opaganib (Yeliva) in patients hospitalised with COVID-19 pneumonia demonstrated positive safety and efficacy signals.

40 patients requiring oxygen support were enrolled in the randomised, double-blind, placebo-controlled study with opaganib. Patients in the study were randomised at a 1:1 ratio to receive either opaganib or placebo on top of standard-of-care (SoC) and were followed up for up to 42 days following treatment initiation.

Top-line results from the study found the drug to be safe, with no material safety differences between opaganib and placebo treatment arms.

Overall, fewer patients suffered from serious adverse events (SAEs) in the opaganib treatment arm than in the placebo arm. In this small sample size, there were few events of intubation or fatality and these were balanced between the two arms.

The opaganib-treated arm demonstrated a consistent trend of greater improvement in reducing oxygen requirement by end of treatment on day 14 across key primary and secondary efficacy outcomes, correlating with clinical improvement as defined by the WHO’s ordinal scale.

Gilead Raday, RedHill’s Chief Operating Officer, said:Opaganib has a unique dual mode of action that is both anti-inflammatory and antiviral – acting on both the cause and the effects of COVID-19.

“Opaganib targets sphingosine kinase-2, a human cell component involved in viral replication and not the virus itself. The mounting evidence of new SARS-CoV-2 mutations emerging globally underscores the importance of this unique mechanism, which potentially minimizes the risk of viral resistance to therapy.”

Darcy Jimenez

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