Novel H. pylori Eradication Therapy Effective in Phase 3 Trial
Talicia (RHB-105; RedHill Biopharma) was found to be effective in the treatment of Helicobacter pylori infection, according to results from a confirmatory Phase 3 study.
Talicia is a novel, fixed-dose oral capsule that combines the antibiotics rifabutin (12.5mg) and amoxicillin (250mg), and the proton pump inhibitor omeprazole (10mg). The ERADICATE Hp2 trial enrolled 455 dyspepsia patients at 55 sites across the US and randomized them to receive 4 capsules, 3 times daily, of either Talicia or the active comparator (amoxicillin 250mg and omeprazole 10mg), for a period of 14 days.
Results showed that in the intent-to-treat population, H. pylori eradication was observed in 84% of patients in the Talicia arm vs 58% of those in the active comparator group (P<.0001). The benefit of Talicia was consistent across all H. pylori culture susceptibility and resistance subgroups; resistance to rifabutin was not detected in the study.
“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,” said Professor David Graham, MD, MACG, lead investigator of the ERADICATE Hp2 study. “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.”
Additional data from ERADICATE Hp2 will be presented at upcoming scientific conferences. RedHill expects to submit the Talicia New Drug Application to the Food and Drug Administration in the first half of 2019.
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