RedHill Biopharma Ltd. announced that the positive final results, announced in June 2015, of the first Phase III study with RHB-105 for the treatment of H. pylori infection were presented by Ira Kalfus, MD, Medical Director at RedHill, at the Innovations in Gastroenterology 2017 Symposium, held in Israel on Friday, January 6, 2017, and received the Second Place Best Abstract Award. RHB-105 is a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection.
The ERADICATE Hp first Phase III study with RHB-105 successfully met its protocol-defined mITT primary endpoint of superiority over historical standard-of-care (SoC) eradication rate of 70%, with high statistical significance (p < 0.001). The study results demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105. Notably, the 89.4% efficacy in eradicating H. pylori infection with RHB-105 was also superior to subsequent open-label treatment with SoC therapies of patients in the placebo arm of the ERADICATE Hp study, which demonstrated only 63% eradication rate in the mITT population (p=0.006). Dr. Kalfus noted that this data further supports the potential efficacy of RHB-105 as a treatment for H. pylori infection. Treatment with RHB-105 appeared to be safe and well tolerated.
A confirmatory Phase III study with RHB-105 is planned to be initiated in the first half of 2017 after completion of an ongoing supportive pharmacokinetic (PK) program.
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 the treatment of H. pylori infection. H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. A first Phase III study with RHB-105 was completed in the U.S. with positive results (the ERADICATE Hp study).
The study demonstrated an overall success rate of 89.4% in eradicating H. pylori, and met its protocol-defined primary endpoint of superiority in eradication of H. pylori infection over historical standard-of-care efficacy levels of 70%, with high statistical significance (p < 0.001). A confirmatory Phase III study is planned to be initiated in the U.S in the first half of 2017. Additional studies may be required, subject to FDA feedback. RHB-105 has been granted Qualifying Infectious Disease Product (QIDP) designation by the FDA, providing a Fast-Track development pathway, as well as NDA Priority Review status, potentially leading to a shorter NDA review time by the FDA, if filed. If approved, RHB-105 will also receive an additional five years of exclusivity, in addition to the standard exclusivity period, for a total of 8 years of U.S. market exclusivity.
