Additional Update on COVID-19 Compassionate Use with Opaganib in Israel Provided by RedHill Biopharma

All five patients have shown an improved CRP, with four of the five patients also demonstrating measurable clinical improvement, including required supplemental oxygenation and higher lymphocyte counts
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Opaganib was administered to all five patients in addition to standard-of-care, including hydroxychloroquine background therapy, and was well tolerated
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Opaganib’s unique mechanism of action has both anti-viral and anti-inflammatory activities, targeting a critical host factor, minimizing potential development of resistance due to viral mutations
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Compassionate use plan in Italy to be converted to a clinical study, in line with the global shift to generate more robust data in a controlled setting for regulatory purposes

TEL-AVIV, Israel and RALEIGH, N.C., April 17, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today 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 (COVID-19) in Israel.

Following the recently announced preliminary findings of clinical improvement in the first two COVID-19 patients treated with opaganib at a leading hospital in Israel, three additional patients have been treated with opaganib, leading to a total of five patients, four of whom have demonstrated measurable improvement within days following treatment initiation.

At the time of treatment initiation, all five patients suffered from moderate to severe acute respiratory symptoms related to SARS-CoV-2 infection, required supplemental oxygenation and were hypoxic despite being treated with supplemental oxygen. The first patient has now completed 14 days of opaganib therapy, safely, with continuous improvement.

Preliminary findings from all five patients have shown an improved C-Reactive Protein (CRP) with four of the five patients also demonstrating measurable clinical improvement, including required supplemental oxygenation and higher lymphocyte counts within days following treatment initiation with opaganib. Two patients were entirely weaned from supplemental oxygenation, one of whom has been discharged from the hospital, and another patient was released from the intensive care unit (ICU) within a few days from treatment initiation with opaganib.