RHB-105 (Talicia®)

RHB-105 (Talicia®) is an investigational 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 and eradication of Helicobacter pylori (H. pylori) infection.

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

RedHill completed two positive Phase 3 studies with RHB-105 (Talicia®) and submitted a New Drug Application (NDA) to the FDA. The NDA was accepted by the FDA and granted Priority Review designation.

The ERADICATE Hp2 study, a two-arm, randomized, double-blind, active comparator-controlled, confirmatory Phase 3 study with RHB-105 (Talicia®) for 
H. pylori infection, 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.

The ERADICATE Hp first Phase 3 study with RHB-105 (Talicia®) also successfully met its primary endpoint of superiority over historical standard of care efficacy levels of 70%, with high statistical significance (p <0.001), demonstrating 89.4% efficacy in eradicating H. pylori infection with RHB-105 (Talicia®). No serious adverse events, new or unexpected safety issues related to the drug were noted in the study.

The ERADICATE Hp2 and ERADICATE Hp Phase 3 studies are registered on, 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.

RHB-105 (Talicia®) was granted Qualified Infectious Disease Product (QIDP) designation by the FDA. 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 RHB-105 (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 marketing application. If approved, RHB-105 (Talicia®) would be eligible to receive an additional five years of U.S. market exclusivity on top of the standard exclusivity period, for a total of 8 years. RHB-105 (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 RHB-105 (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.


RHB-105 (Talicia®) and H. pylori -
Related Documents
RedHill Biopharma RHB-105 Phase III study results - DDW 2017 poster