RedHill Biopharma Receives FDA Approval for COVID-19 Clinical Study with Opaganib in the U.S.

The randomized, double-blind, placebo-controlled study aims to enroll up to 40 patients with moderate-to-severe COVID-19 pneumonia in the U.S.
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All six analyzed moderate-to-severe COVID-19 patients treated with opaganib under compassionate use in Israel were weaned from oxygen and discharged from the hospital
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Opaganib’s unique mechanism of action has both anti-inflammatory and anti-viral activities, targeting a critical host factor, minimizing potential development of resistance due to viral mutations
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Continued progress towards compassionate use and clinical programs in additional countries

TEL-AVIV, Israel and RALEIGH, N.C., May 08, 2020 (GLOBE NEWSWIRE) — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a Phase 2a clinical study evaluating its investigational drug, opaganib (Yeliva^®, ABC294640)¹, in patients with confirmed moderate-to-severe SARS-CoV-2 infection (the cause of COVID-19).

Kevin Winthrop, MD, M.P.H., Professor of Infectious Diseases and Public Health at the OHSU-PSU School of Public Health and Principal Investigator of the study, said: “We are pleased to offer opaganib to hospitalized patients as part of a clinical study and are hopeful to meet the strong unmet need for treatments to decrease the severity and duration of respiratory symptoms due to COVID-19.”

Mark L. Levitt, MD, Ph.D., Medical Director at RedHill, added: “We are grateful to the FDA for the timely review of our IND and look forward to initiating the study. There is a strong scientific rationale for the potential efficacy of opaganib in the treatment of COVID-19, including pre-clinical data demonstrating that opaganib may inhibit viral replication and reduce levels of IL-6 and TNF-alpha, important mediators of inflammation that are elevated in moderate-to-severe COVID-19 patients. This is coupled with encouraging preliminary data from the compassionate use program in Israel, which demonstrated objective measurable clinical improvement in all six patients analyzed, including a decrease in required supplemental oxygenation, higher lymphocyte counts, and decreased CRP levels.”