RedHill Announces Positive Top-Line Results from Confirmatory Phase 3Study with TALICIA for H. pylori Infection
Yay! p<.0001!!!
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.
High resistance to standard-of-care antibiotics observed in the ERADICATE Hp2 study is consistent with the diminishing efficacy of standard-of-care therapies, which has declined to approximately 60%.
The Phase 3 study 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.
Results support potential positioning of TALICIA® as a best-in-class, first-line therapy for treating H. pylori infection, with an estimated 2.5 million patients treated annually in the U.S.
Preparations ongoing for potential NDA submission in H1/2019 and commercial U.S. launch with RedHill’s existing salesforce in H2/2019.
Conference call and live webcast to be held today, Monday, Dec. 3, at 8:30 a.m. EST.
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.”
“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.
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.”
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