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 (GI) diseases, announced today positive top-line results from the ERADICATE Hp2 study, a two-arm, randomized, double-blind, active comparator-controlled, confirmatory Phase 3 study with Talicia (RHB-105)1 for H. pylori infection.
The ERADICATE Hp2 study successfully met its primary endpoint with a high degree of statistical significance, demonstrating 84% eradication of H. pylori infection with Talicia versus 58% in the active comparator arm in the intent-to-treat (ITT) population (p<0.0001). No safety issues were reported in the study and Talicia was found to be well tolerated.
Dror Ben-Asher, RedHill’s CEO, stated: “We are delighted with these excellent top-line results and are preparing for U.S. New Drug Application (NDA) submission, expected in the first half of 2019, subject to FDA feedback. Our established U.S. commercial operations team and GI-focused sales force are well-positioned for the potential U.S. commercial launch of Talicia, expected in the second half of 2019, subject to FDA approval.”
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 ERADICATE Hp2 two-arm, randomized, double-blind, active comparator-controlled 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, a dual therapy amoxicillin and omeprazole regimen at equivalent doses, for a period of 14 days.
The efficacy of current standard-of-care therapies continues to decline and has been reported in literature to be approximately 60%2 due to high resistance of H. pylori bacteria to the antibiotics commonly used in these therapies, primarily clarithromycin and metronidazole.
Preliminary H. pylori culture results taken throughout the ERADICATE Hp2 study from patients across 20 U.S. states confirmed the high resistance3 of H. pylori to the antibiotics most commonly used for treatment, clarithromycin (17% resistance) and metronidazole (43% resistance). Importantly, no resistance to rifabutin, a key component in Talicia’s unique and proprietary formulation, was detected in the study.
Moreover, consistent with the literature describing the diminished efficacy of standard-of-care therapies, preliminary results4 from the open-label part of the ERADICATE Hp2 Phase 3 study showed 64% eradication of H. pylori with these therapies.
Results from the ERADICATE Hp2 study showed consistent 21-29% treatment benefit of Talicia versus the active comparator across all H. pylori culture susceptibility and resistance subgroups, including amoxicillin, clarithromycin and metronidazole.
“The growing resistance of H. pylori to the antibiotics commonly used in standard-of-care therapies was confirmed in this study, which demonstrated the high resistance of the Helicobacter bacteria to clarithromycin and metronidazole. The resulting high failure rates of standard-of-care treatments, estimated at 30-40%, are a major public concern among the medical community worldwide and underscore the urgent need for new H. pylori eradication therapies, especially those utilizing antibiotics where resistance is rare such as amoxicillin and rifabutin,” stated Professor David Graham, M.D., M.A.C.G., lead investigator of the ERADICATE Hp2 study.
The ERADICATE Hp2 Phase 3 top-line results confirm the positive findings demonstrated in RedHill’s previously reported first Phase 3 study (ERADICATE Hp) and further support Talicia’s potential to become a next generation, best-in-class, first-line therapy for treating H. pylori infection. RedHill plans to share ERADICATE Hp2 data in greater detail at upcoming scientific conferences.
Talicia was granted Qualified Infectious Disease Product (QIDP) designation and Fast-Track development designation by the FDA, including eligibility for six-month priority review and a total of eight years of U.S. market exclusivity. Talicia is also covered by U.S. patents which extend patent protection until at least 2034, with additional pending patents and applications in various territories worldwide.
H. pylori bacterial infection affects over 50% of the adult population worldwide5 and 30-40% of the U.S. population6, with an estimated 2.5 million patients treated annually in the U.S.7
H. pylori infection is the strongest risk factor for the development of gastric cancer8 and a major risk factor for development of peptic ulcer disease9.
Ira Kalfus, M.D. RedHill’s medical director, added: “I am thrilled with the study results which support the outstanding efficacy of Talicia for treating H. pylori infection. The excellent results from both Phase 3 studies could position Talicia to become the new standard-of-care, best-in-class, first-line therapy for eradication of H. pylori. I look forward to further discussion with FDA about advancing this potential new therapy for H. pylori infection towards an NDA submission. I would like to thank all the patients, physicians and clinical staff who were involved in this study, as well as the lead investigator of the study, Professor David Graham and the RedHill team for their commitment to benefiting people infected with H. pylori.”
RedHill will continue to analyze the top-line data from the ERADICATE Hp2 study, including antibiotic susceptibility and resistance, and plans to meet with the FDA to present the data and discuss the path towards potential marketing approval of Talicia in the U.S.
The ERADICATE Hp2 study top-line results were provided to RedHill by an independent third-party following an independent analysis and remain subject to completion of the independent review and analysis of the underlying data, including all safety, secondary and other outcome measures, and completion of the Clinical Study Report.