RedHill Biopharma reports its Phase 2/3 study of opaganib in patients with severe COVID-19 pneumonia passes fourth Data Safety Monitoring Board review

RedHill Biopharma Ltd (NASDAQ:RDHL) announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva®, ABC294640) in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a fourth independent Data Safety Monitoring Board (DSMB) review.

The company said the DSMB’s recommendation is based on an analysis of unblinded safety data from the first 255 patients treated for 14 days, extending the total opaganib safety database to about 380 patients.

RedHill said the global Phase 2/3 randomized, double-blind, parallel-arm, placebo-controlled study of opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen, is over 75% enrolled, with completion of enrollment expected in the coming weeks.

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“With approximately 380 patients in the opaganib safety database following this positive fourth DSMB review, we are building a clear picture of the safety profile of opaganib.” said Dr Mark Levitt, medical director at RedHill. ”Moreover, adding together the positive Phase 2 data, the successful DSMB futility reviews and the outcomes from compassionate use of opaganib, we look forward with optimism to the reporting of top-line data from the Phase 2/3 study, which will provide the clearest indication to date of opaganib’s promise in treating COVID-19.”

RedHill recently announced positive top-line safety and efficacy data from the non-powered US Phase 2 study with opaganib in 40 patients with COVID-19 pneumonia, in which opaganib demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14 on top of standard-of-care.

The Phase 2 data also showed no material safety differences between the opaganib and placebo on top of standard-of-care treatment arms – further adding to the growing safety database for opaganib.

Opaganib, a new chemical entity, is a proprietary, first-in-class, small molecule pill that inhibits sphingosine kinase-2 (SK2). It has demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

RedHill noted that opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in-vitro model of human lung bronchial tissue. Additionally, preclinical in-vivo studies have demonstrated opaganib’s potential to ameliorate inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage, and has shown 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.

The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the US National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

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