RedHill Biopharma Ltd (RDHL)

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RedHill's Partner Cosmo Pharmaceuticals Successfully Completes Phase 2 Study of Rifamycin SV-MMX 600mg in IBS-D

https://finance.yahoo.com/news/equitable-bank-completes-issue-5-143800261.html

Mon, January 11, 2021, 2:00 PM GMT+2

TEL AVIV, Israel and RALEIGH, N.C,, Jan. 11, 2021 /CNW/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or "the Company"), a specialty biopharmaceutical company, today reported that its partner, Cosmo Pharmaceuticals (SIX: COPN) ("Cosmo"), announced that it had successfully completed their Phase 2 Proof-of-Concept (POC) clinical trial of Rifamycin SV-MMX 600mg in patients with diarrhea-predominant irritable bowel syndrome (IBS-D).

As part of an exclusive license agreement between RedHill and Cosmo from October 2019 for the U.S. rights to Aemcolo® (rifamycin), RedHill maintains certain rights, including a right of first refusal, in relation to Rifamycin SV-MMX 600 mg in the U.S.

Designed to address the debilitating effects of IBS-D, Rifamycin SV-MMX is delivered at a 600mg dose and with different release features to Aemcolo®. Aemcolo® is approved for travelers' diarrhea (TD) caused by noninvasive strains of Escherichia coli (E. coli) in adults and promoted by RedHill for such use in the U.S.

Cosmo reported that results of the Phase 2 POC study show the achievement of statistical significance in all the study populations (ITT, FAS, m-FAS and PP) for the composite primary endpoint (substantial pain and diarrhea decrease) [OR 3.26 (1.39 – 7.67); p-value 0.0066] and for most secondary endpoints such as adequate relief of IBS-related symptoms [OR 2.18 (1.12 – 4.26); p-value 0.0227] and IBS-related bloating at the end of treatment period [OR 2.13 (1.11 – 4.07); p-value 0.0223].

"We are delighted for our partner, Cosmo, on the positive outcome of this study, which clearly demonstrates the potential for Rifamycin SV-MMX 600mg, if approved, to be an important treatment option in tackling IBS-D," said Dror Ben-Asher, RedHill's CEO.