RedHill Biopharma: ERADICATE Hp2 study meets primary endpoint

RedHill Biopharm announced positive top-line results from the ERADICATE Hp2 study, a two-arm, randomized, double-blind, active comparator-controlled, confirmatory Phase 3 study with Talicia 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, or ITT, population. No safety issues were reported in the study and Talicia was found to be well tolerated. Talicia is a proprietary fixed-dose, all-in-one oral capsule combination of two antibiotics, rifabutin and amoxicillin, and a proton pump inhibitor, or 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% 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 and metronidazole. 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 results 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.

https://thefly.com/landingPageNews.php?id=2831029