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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 the following clinical studies:

  • A randomized, double-blind, placebo-controlled Phase 2 study (NCT04414618) successfully completed, with positive top-line safety and efficacy data announced in Dec. 2020

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

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 novel, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with a preclinically demonstrated triple-action mechanism that inhibits viral replication, reduces hyper-immune inflammatory response and diminishes ARDS-related thrombosis (blood clots) – a dangerous complication of COVID-19 disease – in effect acting on the cause and effect of COVID-19 disease.

Opaganib’s target is a human host cell component involved in viral replication, potentially minimizing the likelihood of resistance due to viral mutations.

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

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. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, completely inhibiting viral replication in an in vitro model of human lung tissue. Treatment of cells infected with SARS-CoV-2 resulted in a dose-depended inhibition of virus production without compromising cell membrane integrity. Results from a preclinical study with opaganib administered at 250mg/kg have also demonstrated a reduction of thrombosis (blood clotting) in an acute respiratory distress syndrome (ARDS) model.

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. 

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. 

RedHill conducted a compassionate use program with opaganib with encouraging results which have been published

RedHill is focused on rapidly progressing its clinical development program for opaganib with the aim of submitting  emergency use applications.

 

 

 1Opaganib is an investigational new drug, not available for commercial distribution.