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RedHill Starts H.pylori Trial

All-in-one treatment intended to treat infection in MALT lymphoma

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

RedHill Biopharma has initiated the patient screening process for a Phase III trial in the U.S. designed to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed Helicobacter pylori (H. pylori) bacterial infection. Initiation of the RHB-105 Phase III study follows the necessary approvals including FDA acceptance of the Company’s Investigational New Drug (IND) application and Institutional Review Board (IRB) approval.

RHB-105 is a new and proprietary fixed-dose combination therapy of two antibiotics and a proton pump inhibitor (PPI), in an all-in-one oral capsule, designed for the treatment of H. pylori bacterial infection, which is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma. The RHB-105 combination was originally developed by Professor Thomas Borody, a leading innovator of therapeutic approaches to gastrointestinal tract diseases. Prof. Borody, a member of RedHill’s Advisory Board, also developed the first triple therapy for H. pylori associated with peptic ulcer disease.

The randomized, double-blind, placebo-controlled Phase III study is expected to enroll 90 subjects with confirmed H. pylori infection and non-investigated dyspepsia in up to ten clinical sites in the U.S. Subjects will be randomized in a 2:1 ratio to receive four capsules three times daily, of either RHB-105 or placebo, for a period of 14 days, and will be assessed for the study’s primary endpoint of eradication of H. pylori infection 28 to 56 days after completion of treatment.

A Phase II study conducted in Australia with the RHB-105 active agents demonstrated an eradication rate greater than 90% in patients who had previously failed at least one course of standard of care therapy for H. pylori infection.
In addition to a potential increase in efficacy, RHB-105’s new and proprietary all-in-one oral capsule formulation offers a convenient treatment regimen, potentially improving overall patient compliance and response.

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