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H. pylori Drug Achieves Positive Results in Phase 3 Study
Talicia, a novel drug for the treatment of Helicobacter pylori, achieved positive top-line results in a phase 3 study, according to a press release from RedHill Biopharma, the manufacturer.
David Graham, MD, MACG, lead investigator for the trial, said the efficacy of current H. pylori therapies are in decline due to the bacteria’s high resistance.
“The resulting high failure rates of standard-of-care treatments, estimated at 30% to 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,” he said in the press release.
The trial — known as ERADICATE Hp2 — was a two-arm, randomized, double-blind, active comparator-controlled study that evaluated the drug in 455 patients with dyspepsia with confirmed H. pylori infection. Patients received four capsules of either Talicia — a combination of rifabutin, amoxicillin and omeprazole — or the active comparator, a dual therapy amoxicillin and omeprazole regimen, three times daily for 14 days.
The trial met its primary endpoint, demonstrating 84% eradication of H. pylori infection with Talicia compared with 58% in the active comparator arm in the intent to treat population (P < .0001).
The study’s findings build on the results of RedHill’s previous phase 3 trial, ERADICATE Hp.
“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,” RedHill medical director Ira Kalfus, MD, said in the press release. I look forward to further discussion with FDA about advancing this potential new therapy for H. pylori infection towards an [new drug application] submission.”
Disclosure: Healio Gastroenterology and Liver Disease could not confirm Graham’s relevant financial disclosures prior to publication. Kalfus is employed by RedHill Bipharma.