RedHill Biopharma Late-Breaking Abstract on Positive Phase III Crohn’s Disease Study with RHB-104 to be Presented at UEG Week 2018

TEL-AVIV, Israel and RALEIGH, N.C., Oct. 10, 2018 (GLOBE NEWSWIRE) -- (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, today announced that a late-breaking abstract on the positive Phase III study with RHB-104 in Crohn’s disease (MAP US study) will be presented at the upcoming United European Gastroenterology Week (UEG Week 2018), October 20-24, 2018, in Vienna, Austria.

The presentation will highlight data from the MAP US Phase III study of RHB-104, including subgroup analysis of treatment with and without anti-TNF agents. Positive top-line results from the MAP US Phase III study were announced in July 2018. The study successfully met its primary endpoint and key secondary endpoints, demonstrating consistent benefit to Crohn’s disease patients treated with RHB-104.

“As additional data from the MAP US Phase III study becomes available, we continue to learn more about the efficacy and safety of orally-administered RHB-104 and its potential to address significant unmet medical needs in Crohn’s disease,” said Ira Kalfus, MD, RedHill’s Medical Director. “We are excited to present this positive top-line data from the MAP US study at the upcoming UEG conference.”

The late breaking abstract, entitled ‘Phase III Randomized, Double Blind, Placebo-Controlled, Multicenter, Parallel Group Study To Assess The Efficacy And Safety Of Add-On Fixed-Dose Anti-Mycobacterial Therapy (RHB-104) In Moderately To Severely Active Crohn's Disease (MAP US)’ will be presented by Professor David Y. Graham, Lead Investigator of the MAP US study, on Monday, October 22, 2018, at 2-3 p.m., Room C (session: Clinical trials in IBD).

About RHB-104:

RHB-104 is a proprietary, orally-administered antibiotic combination therapy, with potent intracellular, antimycobacterial and anti-inflammatory properties, with positive top-line results from a first Phase III study. RHB-104 was developed based on the hypothesis that Crohn’s disease is caused by Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. The development of RHB-104 is consistent with the growing awareness of the possibility that a bacterially-induced dysregulated immune system may contribute to the pathogenesis of various autoimmune diseases of unknown etiology. Positive top-line results from the first Phase III study with RHB-104 in Crohn’s disease (the MAP US study) were announced in July 2018. The study successfully met its primary endpoint and key secondary endpoints. RedHill has conducted several supportive studies with the current formulation of RHB-104 and a population pharmacokinetic (pop-PK) study is ongoing as part of the Phase III MAP US study. Additionally, an open-label extension Phase III study (MAP US2 study) is ongoing to assess the safety and efficacy of RHB-104 in subjects who have completed week 26 assessments in the ongoing Phase III MAP US study and remain with active Crohn’s disease (CDAI ≥ 150). Additional clinical studies are likely to be required to support a U.S. NDA for RHB-104.

About RedHill Biopharma Ltd.:     

RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company, primarily focused on the development and commercialization of late clinical-stage, proprietary drugs for the treatment of gastrointestinal diseases. RedHill commercializes and promotes four gastrointestinal products in the U.S.: Donnatal^® - a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis; Mytesi^® - an anti-diarrheal drug indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy; Esomeprazole Strontium Delayed-Release Capsules 49.3 mg - a prescription proton pump inhibitor indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal conditions, and EnteraGam^® - a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill’s key clinical-stage development programs include: (i) TALICIA^® (RHB-105) for the treatment of Helicobacter pylori infection with an ongoing confirmatory Phase III study and positive results from a first Phase III study; (ii) RHB-104, with positive top-line results from a first Phase III study for Crohn's disease; (iii) RHB-204, with a planned pivotal Phase III study for nontuberculous mycobacteria (NTM) infections; (iv) BEKINDA^® (RHB-102), with positive results from a Phase III study for acute gastroenteritis and gastritis and positive results from a Phase II study for IBS-D; (v) YELIVA^® (ABC294640), a first-in-class SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase IIa study for cholangiocarcinoma; (vi) RHB-106, an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd. and (vii) RHB-107 (formerly MESUPRON), a Phase II-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases.

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