RedHill Biopharma Ltd. announced Tuesday additional supportive data from the first Phase III study with RHB-105 for eradication of H. pylori.
The study of the treatment of patients in the placebo arm with standard-of-care therapy for persistent H. pylori infection showed a lower eradication rate compared to the previously eradication rate demonstrated in the RHB-105 arm of the controlled study.
"The study's results of 63 percent eradication rate of H. pylori infection with standard-of-care are in-line with recent literature and clinical experience and are indicative of the increasing and alarming rates of resistance of H. pylori bacteria to SoC treatment,” David Graham, a professor at the Baylor College of Medicine and a key opinion leader in the field of gastric cancer and H. pylori infection and Principal Investigator of the ERADICATE Hp Study, said. “Furthermore, it strengthens the RHB-105 Phase III study's primary endpoint results, and supports the potential superior efficacy of RHB-105 over SoC, with an 89.4 percent eradication rate.”
H. pylori is a leading cause of gastric cancer, peptic ulcer disease and MALT lymphoma. Cure rates for the infection are currently declining.
"The positive top-line results from the first Phase III study with RHB-105 and the new SoC data lead us to believe that RHB-105 can potentially be positioned as a best-in-class, first-line therapy for eradication of H. pylori,” Gilead Raday, RedHill's senior vice president of corporate and product Development, said.
RedHill plans to meet with the FDA soon to discuss the future development plan of RHB-105.