RedHill Biopharma Announces Presentation Of Positive Oral Opaganib Phase 2 Data In COVID-19

Positive U.S. Phase 2 safety and efficacy data for opaganib, a leading novel, oral, dual-mechanism drug candidate for moderate-to-severe COVID-19, presented at the World Microbe Forum Opaganib was associated with a reduction in the need for supplemental oxygen support, earlier time to discharge from hospital and was well tolerated Opaganib's global 475-patient Phase 2/3 study is fully enrolled, with study completion expected in the coming weeks Opaganib is host-targeted and expected to be effective against emerging viral variants TEL AVIV, Israel and RALEIGH, NC, June 21, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation of the positive Phase 2 safety and efficacy data for oral opaganib (Yeliva®, ABC294640)[1] in hospitalized patients with COVID-19 pneumonia at the World Microbe Forum Results and post hoc analyses of data from the 40-patient U.S. Phase 2 study were presented in a poster entitled, "Opaganib, an Oral Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: A Randomized, Double-blind, Placebo-controlled Phase 2A Study, in Adult Subjects Hospitalized with SARS-CoV-2 Positive Pneumonia (NCT: 04414618)"[2]. Patients in the study were randomized to receive either opaganib or placebo in addition to standard of care (SoC), predominantly including dexamethasone and/or remdesivir. Findings include: 50% of patients treated with opaganib (n=22) reached room air by Day 14 compared to 22% in the placebo group (n=18). The benefit of reaching room air by Day 14 for patients on opaganib was maintained regardless of whether the patients were receiving dexamethasone and/or remdesivir 86.4% of patients treated with opaganib were discharged from hospital by Day 14 compared to 55.6% of patients treated with placebo Median time to discharge was 6 days for the opaganib group compared to 7.5 days for the placebo group 81.8% of opaganib patients achieved a 2-point improvement in the WHO Ordinal Scale compared to 55.6% of patients in the placebo group – achieved in a median time of 6 days versus 7.5 days, respectively No significant differences in safety-related measures between the two groups (with diarrhea being the main treatment-emergent difference in tolerability) "The need for an effective oral therapy to treat COVID-19 is clear. Such a therapy would greatly improve our ability to manage this pandemic," said Kevin Winthrop, MD, MPH, Professor of Infectious Diseases at Oregon Health & Science University, who presented the findings at WMF. "These data, from this proof-of-concept clinical study of opaganib in patients with severe COVID-19, suggest a potential role of SK2 inhibition in combating the effects of this virus. With much more data on opaganib expected in the coming weeks, we could make some real progress toward having access to a much-needed oral therapy for patients who currently have a paucity of options available to them."

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