Replies to post #2489 on RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma on go with mid-stage study with second COVID-19 candidate

Nov. 17, 2020 9:05 AM ETRedHill Biopharma Ltd. (RDHL)By: Vandana Singh, SA News Editor

The FDA has signed-off RedHill Biopharma's (NASDAQ:RDHL) Phase 2/3 study evaluating RHB-107 (upamostat) in patients with symptomatic COVID-19 who do not require hospitalization.

RHB-107 is an orally administered potent inhibitor of several serine proteases. RedHill licensed RHB-107 (formerly Mesupron) from Heidelberg Pharma.

The Phase 2/3 study is expected to start enrolling patients early next year, and primary endpoints will be time to recovery from symptomatic illness compared to placebo, as well as safety and tolerability of RHB-107. Several secondary and exploratory endpoints will also be assessed.

Yesterday, the company concluded patient enrollment in U.S. Phase 2 study evaluating opaganib in patients hospitalized with severe COVID-19 pneumonia.

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In parallel, RedHill is rapidly advancing its development program with opaganib in severe COVID-19 pneumonia; The U.S. Phase 2 study is fully enrolled with topline data expected within weeks, and a global Phase 2/3 study which is more than 50% enrolled, with topline data expected in Q1/2021 in support of potential emergency use applications