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RHB-105 Shows Efficacy for H. pylori Eradication
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RedHill Pharmaceuticals today announced positive results from its phase 3 study of RHB-105 for treatment of Helicobacter pylori infection, according to a press release.
RHB-105 is a new oral capsule with a fixed-dose combination of two antibiotics and a proton pump inhibitor with a planned indication of H. pylori infection, the release said. The study (ERADICATE Hp) was conducted at 13 U.S. clinical sites and included 118 dyspepsia patients with confirmed H. pylori infection who were randomly assigned to receive RHB-105 or placebo for 2 weeks and were then assessed for H. pylori eradication 28 to 35 days after treatment.
According to the release, the results showed RHB-105 had 89.4% efficacy in eradicating H. pylori and met its primary endpoint of superiority compared with 70% efficacy levels achieved with historical standard of care (P < .001). Furthermore, no serious adverse events or unexpected safety issues occurred.
An independent third party provided the results to the manufacturer after an independent analysis, and they “remain subject to completion of the independent review and analysis of the underlying data, including all safety, secondary and other outcome measures, and completion of the clinical study report, expected in the third quarter of 2015,” the release said.
These results “are consistent with the hypothesis that this may represent a promise for a new and improved treatment for H. pylori infection, and could significantly contribute to the prevention of gastric cancer, MALT lymphoma and other gastrointestinal diseases and conditions,” David Graham, MD, MACG, study investigator from Baylor College of Medicine in Texas, said in the release. “Given the current high levels of antibiotic resistance and treatment failures with current standard of care therapies, RHB-105 could become, if approved, a best-in-class treatment, improving and potentially saving patients’ lives.”
RHB-105 was previously designated by the FDA as a qualified infectious disease product (QIDP) under the Generating Antibiotic Incentives Now Act, which extends fast-track development benefits to the manufacturer, the release said. If approved, the drug will also receive an additional 5 years of U.S. market exclusivity.
“On the basis of the clear success of the ERADICATE Hp study, and the Fast-Track designation of RHB-105, we look forward to meeting with FDA to discuss the clinical and regulatory path towards marketing approval in the U.S.,” Ira Kalfus, MD, RedHill’s medical director, said in the release. “No new or unexpected safety issues were identified. Efficacy and safety data from this study will be submitted for presentation at an upcoming medical meeting.”
Redhill is currently pursuing an indication of first-line treatment of H. pylori infection, regardless of ulcer status, which is a broader indication than current standard treatments. The company has also planned a second phase 3 study, “and additional studies may be required, subject to FDA feedback,” the release said.
“We are enthusiastic about the strong phase 3 top-line results of RHB-105 and its potential benefit to patients,” Gilead Raday, RedHill’s senior vice president of corporate and product development, said in the release. “Coupled with the QIDP designation, patent protection and expanded indication, RHB-105 should be well-positioned, if approved, for commercial success as a first-line therapy for the treatment of H. pylori infection.”
Disclosure: Graham reports he is a consultant for RedHill. Kalfus and Raday are employees of RedHill.