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RedHill Biopharma Provides Update On Compassionate Use Program With Opaganib

Biopharmaceutical company RedHill Biopharma Ltd. (RDHL) on Monday provided an additional update on the compassionate use program with its investigational drug, opaganib (Yeliva, ABC294640)1, in patients with confirmed SARS-CoV-2 infection (the cause of COVID-19) in Israel.

At the time of treatment initiation, all of the patients were hospitalized, suffered from moderate-to-severe acute respiratory symptoms related to SARS-CoV-2 infection and were treated with standard-of-care (mostly hydroxychloroquine). All patients required supplemental oxygenation and were hypoxic despite being treated with supplemental oxygen.

Preliminary data in moderate-to-severe COVID-19 patients treated with opaganib show measurable clinical improvement in all six patients analyzed, including decreased requirement for supplemental oxygenation, higher lymphocyte counts and decreased CRP

Five of the six patients analyzed were weaned from oxygen, and three were discharged from the hospital within days of treatment initiation. The 6th patient, whose therapy was initiated more recently, is improving. To date, two patients have safely completed 14 days of opaganib therapy, which has been well tolerated.

A 7th patient who was treated with hydroxychloroquine and azithromycin suffered from side effects of diarrhea, which resolved quickly following cessation of all therapies. This patient received only 1 day of opaganib dosing and therefore was not included in this analysis.

Opaganib has been well tolerated and no patient required mechanical ventilation following treatment with opaganib

RedHill recently announced that it has submitted an Investigational New Drug (IND) application to the FDA to evaluate the safety and efficacy of opaganib in a randomized, double-blind, placebo-controlled Phase 2a study in patients hospitalized with positive SARS-CoV-2 and pneumonia in the U.S.

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