Orally-Administered Opaganib for Severe COVID-19 Study Expands in the USA
Tel Aviv-based RedHill Biopharma Ltd. announced its plans to expand the Company's global Phase 2/3 study of opaganib in patients with severe COVID-19, following U.S. Food and Drug Administration (FDA) review of the data from the Phase 2 study of opaganib and receipt of its recommendations.
Opaganib (Yeliva®, ABC294640), a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
On February 23, 2021, the company's press statement indicated the expansion of the global Phase 2/3 study to the USA would entail adjustments to the protocol based on the FDA's recommendations and ongoing discussions. Furthermore, the expansion of this clinical study to the USA will speed-up enrollment, include a total of 8 countries and at approximately 40 recruiting sites. The 464-patient study is over 50% enrolled and is expected to deliver top-line data in the second quarter of 2021.
Opaganib has received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma.
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases.