RedHill Biopharma announces positive FDA meeting on RHB-105 path to approval and planned confirmatory Phase III study for H. pylori infection

The FDA has confirmed, subject to final minutes of the meeting, the planned two-arm, randomized, double-blind, active comparator design of the confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection, expected to be initiated in the second half of 2016.

“We are very pleased with the outcome of the FDA meeting and would like to thank the Agency for its constructive feedback,” said Gilead Raday, Chief Operating Officer. “The FDA meeting provided a pathway for potential marketing approval of RHB-105 in the US. We plan to initiate the RHB-105 confirmatory Phase III study discussed with the FDA during the second half of 2016 and hope to bring this new potential blockbuster drug to the market as soon as possible as a best-in-class, first-line therapy for eradication of H. pylori.”

RedHill met with the FDA to discuss the successful results of the recently completed first Phase III study with RHB-105 (the ERADICATE Hp study) and the proposed design of the confirmatory Phase III study for the treatment of H. pylori infection. As a result of the productive and supportive feedback received from the FDA, RedHill intends, subject to finalization of the FDA meeting minutes, to complete the design of the planned confirmatory Phase III randomized, double-blind, active comparator, two-arm clinical study, comparing RHB-105 against a high dose amoxicillin and omeprazole regimen. As per FDA recommendation, RedHill will complete a supportive pharmacokinetic (PK) program prior to initiating the confirmatory Phase III study in the second half of 2016. Subject to a successful outcome, the confirmatory Phase III study and supportive PK program are expected to complete the clinical package required for a US New Drug Application (NDA) for RHB-105. H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. H. pylori infection is estimated to affect over half of the adult population worldwide. The growing resistance of the H. pylori bacteria to metronidazole and clarithromycin has resulted in increasing failure rates of current standard-of-care therapies (SoC) for H. pylori eradication, reaching an estimated 30%. Despite the strong unmet medical need, no new drug has been approved by the FDA for this indication in over a decade. The 2015 US and global market potential for H. pylori eradication therapies, at current branded prices, were estimated at approximately $1.45 billion and $4.83 billion, respectively, and could potentially grow with increasing awareness of the health risks associated with H. pylori infection and the benefits of its eradication(2). The ERADICATE Hp first Phase III study with RHB-105 successfully met its protocol-defined primary endpoint of superiority over historical SoC eradication rate levels of 70%, with high statistical significance (p<0.001). The final results demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105. Subsequent open-label treatment of patients in the placebo arm with SoC therapy for persistent H. pylori infection demonstrated a 63% eradication rate with SoC, further supporting the potential superior efficacy of RHB-105 over SoC. RHB-105 was also shown to be safe and well-tolerated. RHB-105 has been granted Qualifying Infectious Disease Product (QIDP) designation by the FDA, providing a Fast-Track development pathway, as well as Priority Review status, potentially leading to a shorter review time by the FDA of a NDA, if filed. If approved, RHB-105 will also receive an additional 5 years of US market exclusivity, in addition to the standard exclusivity period, for a total of 8 years of market exclusivity. 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 indicated only for patients with active or recent history of duodenal ulcer disease. 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 for this drug candidate.