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Opaganib - COVID-19

Opaganib - COVID-19

There is an urgent need for effective new therapies to help decrease the severity and duration of respiratory symptoms due to SARS-CoV-2 infection (the cause of COVID-19). RedHill is working to develop opaganib (Yeliva, ACB294640)1 for COVID-19.

Opaganib has a unique mechanism of action, with both anti-inflammatory and anti-viral activity, targeting a critical host factor, which minimizes the potential development of resistance due to viral mutations.

RedHill is advancing a development program evaluating opaganib as a therapy for patients with severe COVID-19 infection, which includes two ongoing clinical studies:

  • global randomized, double-blind, parallel-arm, placebo-controlled global Phase 2/3 study (NCT04467840)

  • A U.S. randomized, double-blind, placebo-controlled Phase 2 study (NCT04414618)

Prior to the initiation of the COVID-19 clinical studies, approximately 140 subjects had  been dosed with opaganib in ongoing and completed Phase 1 and Phase 2 clinical studies in oncology indications, in pharmacokinetic studies in healthy volunteers in the U.S., under the existing FDA-approved expanded access requests from physicians for individual oncology patients and under expanded access for COVID-19 patients in Israel, establishing safety and tolerability in humans both in the U.S. and ex-U.S. 

Pre-clinical data have demonstrated both anti-inflammatory and anti-viral activities of opaganib, with the potential to reduce lung inflammatory disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Several prior pre-clinical studies support the potential role of sphingosine kinase-2 (SK2) in the replication-transcription complex of positive-strand single-stranded RNA viruses, similar to coronavirus, and its inhibition may potentially inhibit viral replication. Pre-clinical in vivo studies have demonstrated that opaganib decreased fatality rates from influenza-virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids. 

RedHill conducted a compassionate use program with opaganib in Israel with encouraging results which have been published. Analysis of treatment outcomes showed substantial benefit to the patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital.

RedHill is focused on rapidly progressing its clinical development program for opaganib and aims to have sufficient data to support emergency use applications.

 

 1Opaganib is an nvestigational new drugs, not available for commercial distribution.