RedHill Biopharma (RDHL) Commences Enrollment in RHB-105 Phase 3 as H. Pylori Treatment
RedHill Biopharma (NASDAQ: RDHL) announced that the last patient enrolled in the first Phase III study with RHB-105 for the treatment of Helicobacter pylori (H. pylori) bacterial infection has completed the treatment course with the investigational product, RHB-105, for primary endpoint evaluation. Top-line results from this study are expected in the third week of June 2015, subject to completion of review requirements.
The randomized, placebo-controlled, Phase III study (the ERADICATE Hp study) is intended to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed H. pylori bacterial infection, a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma. If successful, the ERADICATE Hp Phase III study is planned to be followed by a second Phase III study and additional studies may be required, subject to FDA feedback. A total of 118 non-investigated dyspepsia patients with confirmed H. pylori infection were enrolled and treated in the ERADICATE Hp study, which was conducted in the U.S. Subjects were randomized in a 2:1 ratio to receive either RHB-105 or a placebo for a period of 14 days and assessed for the eradication of H. pylori infection 28 to 35 days after completion of treatment. The primary endpoint of the study is to show superiority in eradication of H. pylori infection over historical standard of care efficacy levels of 70% effectiveness.
With RHB-105, RedHill is pursuing an indication of first line treatment of H. pylori infection regardless of ulcer status, a significantly broader indication than current standard treatments for H. pylori, which are typically limited and indicated to treat patients with an active or recent history of ulcers. If approved, RHB-105 may be the first H. pylori eradication therapy to target this broader indication, which would significantly expand the potential patient population on the label for this drug candidate.
RHB-105 was designated by the FDA as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act, which is intended to incentivize the development of new antibiotic drugs for the treatment of serious or life-threatening infections. The designation allows RedHill to benefit from fast-track development status for RHB-105, providing for an expedited development pathway, as well as priority review status, potentially leading to a shorter review time by the FDA of a New Drug Application (NDA), if filed. If approved, RHB-105 will also receive an additional five years of U.S. market exclusivity in addition to the standard exclusivity period, for a total of 8 years of market exclusivity.
The 2015 global and U.S. market potential for H. pylori eradication therapies, at current branded prices, was recently estimated at approximately $4.83 billion and $1.45 billion, respectively, and could potentially grow with increasing awareness of the health risks associated with H. pylori infection and the benefits of its eradication1.
Market Data 
Markets 
AI
