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Opaganib - COVID-19

Opaganib - COVID-19

RedHill is developing opaganib (Yeliva, ACB294640)1 to address the strong unmet need for therapies to decrease the severity and duration of respiratory symptoms due to SARS-CoV-2 infection (the cause of COVID-19).

Opaganib’s unique mechanism of action has both anti-inflammatory and anti-viral activities, targeting a critical host factor, minimizing potential development of resistance due to viral mutations.

The U.S. Food and Drug Administration (FDA) has cleared RedHill’s Investigational New Drug (IND) application for a randomized, double-blind, placebo-controlled Phase 2a study evaluating opaganib in patients with moderate-to-severe COVID-19 infection.

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. 

Approximately 140 subjects have been dosed with opaganib to date 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. 

A compassionate use program with opaganib is ongoing in Israel with preliminary positive outcomes. RedHill is working diligently to expand access to opaganib to patients in additional countries.

To find out more about RedHill Biopharma’s Expanded Access policy, please visit: www.redhillbio.com/expandedaccess

 

 

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