ARDS-induced thrombosis may occur in up to one-third of COVID-19 patients requiring ICU admissions and is a contributing cause of mortality. Opaganib has demonstrated the ability to reduce thrombosis in a preclinical model of ARDS. Opaganib has also been shown to inhibit SARS-CoV-2 viral replication as well as pro-inflammatory markers in relevant preclinical models. Top-line data from the U.S. Phase 2 (NCT04414618) study of orally administered opaganib in patients with severe COVID-19, evaluating the safety and potential efficacy signals, is expected in December 2020.
Opaganib is a novel, orally administered sphingosine kinase 2 (SK2) selective inhibitor, administered at 250mg/kg, demonstrating a reduction of thrombosis (blood clotting) in an acute respiratory distress syndrome-preclinical animal model designed to measure thrombotic risks. Opaganib has also shown anti-inflammatory and antiviral activity that acts on both the cause and the effects of COVID-19 disease, targeting a host cell component involved in viral replication, potentially minimizing the likelihood of resistance due to viral mutations. Additionally, preclinical 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.
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