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Opaganib - COVID-19

Opaganib - COVID-19

RedHill’s development program for opaganib as a potential therapy for patients with severe COVID-19 infection includes two ongoing clinical studies:

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

  • AS. randomized, double-blind, placebo-controlled Phase 2 study (NCT04414618)

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 is a first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with dual anti-inflammatory and antiviral activity that targets a host cell component, unaffected by viral mutation, thus minimizing the likelihood of resistance.

Opaganib demonstrated potent anti-SARS-CoV-2 activity, achieving complete blockage of viral replication in an in vitro model of human lung tissue (EpiAirway™).

Prior to the initiation of the COVID-19 clinical studies, approximately 140 subjects had received opaganib in a range of Phase 1 and 2 clinical studies, pharmacokinetic studies and in various oncology and COVID-19 compassionate use programs in the U.S. and abroad, establishing its safety and tolerability profile. 

Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to reduce inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. The latest study showed a clear antiviral effect of opaganib against SARS-CoV-2, completely inhibiting viral replication in an in vitro model of human lung tissue and demonstrating the most potent activity compared to all compounds tested, including remdesivir. Treatment of cells infected with SARS-CoV-2 resulted in a dose-depended inhibition of virus production without compromising cell membrane integrity.

Additionally, 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 with encouraging results which have been published. Analysis of treatment outcomes showed substantial benefit to the patients treated with opaganib 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 investigational new drugs, not available for commercial distribution.