RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma to Host Analyst and Investor Webcast on TALICIA® for H. pylori infection on October 30, 2018



Top-line results from the ERADICATE Hp2 confirmatory Phase III study expected before year-end 2018

H. pylori bacterial infection affects over 50% of the adult population worldwide and 30-40% of the U.S. population

TEL-AVIV, Israel and RALEIGH, N.C., Oct. 29, 2018 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (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 it will host an analyst and investor webcast on TALICIA® for H. pylori infection, tomorrow, Tuesday, October 30, 2018, at 8:30 a.m. EDT.

RedHill recently announced that the final patient was assessed for primary endpoint in the confirmatory Phase III study with TALICIA® (RHB-105)1 for H. pylori infection (ERADICATE Hp2 study). Top-line results are expected to be announced before year-end 2018.

Members of RedHill’s executive team will be joined by the study’s lead investigator and key opinion leader, Professor David Y. Graham, M.D., M.A.C.G., and will discuss TALICIA®, the ERADICATE Hp2 study, H. pylori infection, the current treatment landscape and potential market. A question and answer session will be held following the presentations.

The conference call, including a slide presentation, will be broadcast live and available for replay for 30 days on the Company's website, http://ir.redhillbio.com/events. Please access the website at least 15 minutes ahead of the conference call to register.

Participants who wish to ask questions during the event can do so by dialing into the event. To participate in the conference call, please dial one of the following numbers 5-10 minutes prior to the start of the call: United States: [phone]; International: [phone]; and Israel: [phone]. The access code for the call is: 5774327.

The ERADICATE Hp2 study is a two-arm, randomized, double-blind, active-comparator, confirmatory Phase III study which compares TALICIA® against a dual therapy amoxicillin and omeprazole regimen at equivalent doses. The study investigated 455 dyspepsia patients with confirmed H. pylori infection at 55 clinical sites across the U.S. Subjects were randomized 1:1 to receive four capsules, three times daily, of either TALICIA® or the active comparator, for a period of 14 days. Subjects were assessed for the study’s primary endpoint of eradication of H. pylori infection at least 43 days after initiation of treatment. The study is 90% powered to detect a 13% treatment effect (active arm 83% vs. control arm 70%).

Prof. David Y. Graham, MD, M.A.C.G.
Professor David Y. Graham, MD, an internationally renowned researcher and physician of Baylor College of Medicine, is the lead investigator for the ERADICATE Hp2 study. Prof. Graham is the author of more than 800 scientific articles, several books, and 100 chapters in medical text books. He is a Master of the American College of Gastroenterology and a Fellow of the American College of Physicians, the American Academy of Microbiology, the American Association for the Advancement of Science, the Infectious Diseases Society of America, and World Innovation Foundation. Professor Graham is a former president of the American College of Gastroenterology.

About TALICIA®:
TALICIA® is a novel and proprietary fixed-dose, all-in-one oral capsule combination of two antibiotics, rifabutin and amoxicillin, and a proton pump inhibitor (PPI), omeprazole.

The first Phase III study with TALICIA® (ERADICATE Hp study) successfully met its primary endpoint of superiority over historical standard-of-care (SoC) eradication rate of 70%, with high statistical significance (p<0.001). The study results demonstrated 89.4% efficacy in eradicating H. pylori infection with TALICIA®. Notably, these results were also superior to subsequent open-label treatment with SoC therapies of patients in the placebo arm of the ERADICATE Hp study, which demonstrated 63% eradication rate (p=0.006), further supporting the potential efficacy of TALICIA®. Treatment with TALICIA® was shown to be safe and well tolerated and eliminates concerns of resistance to current SoC.

The ERADICATE Hp2 confirmatory Phase III study with TALICIA® (RHB-105) is registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health (NIH), which provides access to information on publicly and privately supported clinical studies.

About H. pylori:
H. pylori bacterial infection affects over 50% of the adult population worldwide2 and 30-40% of the U.S. population3, with an estimated three million patients treated annually in the U.S. H. pylori is classified as a group I carcinogen by the International Agency for Research on Cancer. It is the strongest risk factor for the development of gastric cancer2 and a major risk factor for peptic ulcer disease, and gastric mucosa-associated lymphoid tissues (MALT) lymphoma4. Eradication of H. pylori is becoming more difficult; current standard-of-care therapies fail in approximately 30% of patients, who remain H. pylori positive, due to increasing resistance of H. pylori to antibiotics commonly used in standard combination therapies5. Clarithromycin-resistant H. pylori was formally categorized by the World Health Organization as a pathogen for which there is a high priority need to develop new treatments6.

The 2018 global market for H. pylori eradication therapies is estimated at approximately $4.8 billion, of which $1.4 billion is from the U.S.7


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.