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TALICIA® (H. pylori)

TALICIA® (RHB-105) is a new and proprietary fixed-dose oral combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule with a planned indication for treatment of Helicobacter pylori (H. pylori) infection.

H. pylori infection is the strongest risk factor for the development of gastric cancer and a major risk factor for development of peptic ulcer disease. 

RedHill announced in December 2018 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 (ITT) population (p<0.0001). No safety issues were reported in the study and TALICIA® was found to be well tolerated.

TALICIA® completed a first Phase III study for the treatment of Helicobacter pylori (H. pylori) bacterial infection (ERADICATE Hp study). The ERADICATE Hp first Phase III study with TALICIA® successfully met its primary endpoint of superiority over historical standard of care efficacy levels of 70%, with high statistical significance (p <0.001). No serious adverse events, new or unexpected safety issues related to the drug were noted in the study. The results from the study demonstrated 89.4% efficacy in eradicating H. pylori infection with TALICIA®.

The ERADICATE Hp2 and ERADICATE Hp Phase 3 studies are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health which provides public access to information on publicly and privately supported clinical studies.

Following discussions with the FDA, RedHill announced in August 2014 that it had received authorization from the FDA to pursue a new and significantly broader indication with TALICIA®. While current standard treatments for H. pylori are typically indicated to treat patients with active or recent history of ulcers, TALICIA®’s new intended indication will target H. pylori infection as a first line treatment regardless of ulcer status.

TALICIA® was granted Qualified Infectious Disease Product (QIDP) designation and Fast-Track development designation by the FDA in November 2014. The QIDP designation was granted under the FDA’s Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections. The QIDP designation allows TALICIA® to benefit from fast-track development status with an expedited development pathway and from priority review status which provides for a shorter review time by the FDA of a future potential marketing application. If approved, TALICIA® will also receive an additional five years of U.S. market exclusivity on top of the standard exclusivity period, for a total of 8 years. TALICIA® is also covered by U.S. patents which extend patent protection until at least 2034, with additional pending patents and applications in various territories worldwide.

The TALICIA® combination was originally developed as a next-generation therapy by Professor Thomas Borody, a leading innovator of therapeutic approaches to gastrointestinal tract diseases, who developed the first approved triple therapy treatment for H. pylori associated with peptic ulcer disease.