Research & Development
RedHill Biopharma Ltd concludes treatment and follow-up of global phase 2/3 study in patients hospitalised with severe COVID-19 pneumonia
20 July 2021 -

Pharmaceutical company RedHill Biopharma Ltd (Nasdaq:RDHL) revealed on Monday the completion of all treatment and follow-up under its global phase 2/3 study of 475 opaganib (ABC294640) in hospitalised patients with severe COVID-19 pneumonia.

Opaganib, a new chemical entity, is a novel and patented selective inhibitor of sphingosine kinase 2 (SK2) that is administered orally, with a unique demonstrated effect of dual anti-inflammatory and antiviral activity that targets the host and expected to be effective against emerging viral variants, stated the company.

Top-of-the-line results of Opaganib are expected in the coming weeks, added the company. The primary endpoint is the proportion of patients breathing room air without oxygen support on day 14.

Recently, Opaganib has demonstrated potent in vitro inhibition of Beta (South African) and Gamma (Brazilian) variants and is expected to maintain its activity as well against emerging variants, including Delta and Delta Plus, the company also disclosed.

In addition, the use of the opaganib has been promoted in Israel and Switzerland under the compassionate use exemption. The company is in discussions with the US FDA, EMA and other regulatory bodies about possible avenues for approval and the next steps will be guided by the results of the studies. Discussions are taking place with potential partners interested in opaganib rights in several countries.

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