H. Pylori Infection Treatment Nears FDA Judgement

TALICIA will undergo a confirmatory Phase III trial.

H. pylori infection treatment RHB-105 (TALICIA) will undergo a Phase III trial study.

TALICIA is a proprietary, fixed-dose oral combination capsule drug comprised of 2 antibiotics and a proton pump inhibitor (PPI) designed to eradicate the digestive tract bacteria H. pylori.

Specialty biopharmaceutical company Redhill Biopharma, Ltd., announced TALICIA will be compared against an amoxicillin and omeprazole dual therapy regimen in the randomized, double-blind Phase III study.

The study plans to enroll 444 non-investigated dyspepsia patients with confirmed H. pylori infection, from up to 65 clinical sites in the US Patients will be evenly randomized to receive 3 daily treatments of 4 capsules, of either TALICIA or the equivalent-dose, dual therapy comparative drug. Treatment will last for 14 days, and patients will be assessed for the study’s primary endpoint (H. pylori eradication) at 42 and 70 days after beginning treatment.

The trial is a confirmatory study to an already successful Phase III TALICIA trial, in which the treatment reported an overall 89.4% success rate in eradicating H. pylori infection, and met its protocol-defined primary endpoint of superiority in eradication of H. pylori over historical standard-of-care efficacy levels of 70% with high statistical significance.

TALICIA was granted a Qualifying Infectious Disease Product (QIDP) designation by the FDA, which provides the treatment a fast-track development pathway and drug approval priority review status, if filed.

Dependent on a successful confirmatory Phase III trial outcome and additional regulatory feedback, RedHill anticipates the study, when coupled with the initial Phase III study and supplemental data, will support a potential US New Drug Application (NDA) for TALICIA.

H. pylori is a major cause of peptic ulcer disease, chronic gastritis, gastric cancer, and mucosa-assocaited lymphoid tissue. It currently designated as a high-priority bacteria for which new treatments are urgently needed by the World Health Organization.

RedHill intends to pursue an indication of first-line treatment of the infection. This indication is significantly broader than current standard H. pylori treatments, which are usually indicated only for patients with active or recent history of duodenal ulcer disease. TALICIA may be the first H. pylori eradication therapy in the US to target this indication, if approved.

If the FDA approves a potential TALICIA NDA, the treatment will receive an additional 5 years of US market exclusivity, aside from the standard 3 years of exclusivity provided.

A press release regarding the trial was made available.

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