The results indicate that the drug reduces thrombosis, or blood clotting, in a preclinical animal model of acute respiratory distress syndrome (ARDS), one of the potentially life-threatening complications of COVID-19.
Opaganib is a novel, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that acts on both the cause and the effects of COVID-19. Opaganib targets a host cell component involved in viral replication, potentially minimizing the likelihood of resistance due to viral mutations.
ARDS-induced thrombosis may occur in up to a third of COVID-19 patients under intensive care and up to 9% of all hospitalized patients.
Opaganib has also demonstrated the ability to inhibit replication of the SARS-CoV-2 virus that causes COVID-19. The treatment has also been shown to inhibit pro-inflammatory markers in relevant preclinical models.
“There are currently very limited options available to physicians that have been shown to be effective against ARDS, and specifically against ARDS-induced thrombosis,” Reza Fathi, RedHill’s senior vice president of research and development said in a statement.
“Results from our study show opaganib 250 mg/kg reduced blood clot length, weight and total thrombus score in a preclinical model of ARDS. This adds to the known antiviral and anti-inflammatory activities of opaganib and provides the potential for a unique triple-action effect on the pathophysiological processes associated with COVID-19 disease.”
Fathi added that RedHill expects to see topline clinical data insights into the safety and potential efficacy signals of opaganib from the non-powered US Phase 2 study by the end of December. The last patient in the study was given their last dose on November 26.
Sebastien Labbe, director, translational research at IPS Therapeutique Inc, who conducted the study, told investors that the results are “impressive” and provide reason for promise.
“(The) ARDS thrombosis model used to conduct the work is validated and highly predictive,” Labbe said. “The results provide insight into a highly desirable potential effect of opaganib for use in managing patients with severe COVID-19, whose prognosis can be very poor.”
Topline data from the larger global Phase 2/3 study, which is powered for efficacy with more than 60% enrollment, is expected in 1Q 2021.
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