RedHill Biopharma Ltd. announced that it has concluded a positive Type B Meeting with the U.S. Food and Drug Administration (FDA) discussing the chemistry, manufacturing and controls (CMC) aspects of the RHB-105 Phase III development program. RHB-105 is a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection.
Subject to final minutes of the meeting, the FDA has accepted RedHill's manufacturing plan towards filing the CMC package as part of a potential U.S. New Drug Application (NDA) to be submitted for RHB-105, subject to successful completion of the planned confirmatory Phase III study.
Following a previous positive FDA meeting announced in April 2016, and in light of guidance received on the potential path for marketing approval of RHB-105, advanced preparations continue for the confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection. The two-arm, randomized, double-blind, active comparator confirmatory Phase III study, comparing RHB-105 against a high-dose amoxicillin and omeprazole regimen, is planned to be initiated in the first half of 2017, after completion of the ongoing supportive pharmacokinetic (PK) program. The confirmatory Phase III study is planned to enroll approximately 440 patients in up to 55 clinical sites in the U.S.
The planned confirmatory Phase III study, along with the results from the successfully completed first Phase III study with RHB-105 (the ERADICATE Hp study) and data to be obtained from the ongoing supportive PK program, are expected to support an NDA for RHB-105.
The ERADICATE Hp Phase III study with RHB-105 successfully met its primary endpoint of superiority over historical standard-of-care (SoC) eradication rate of 70%, with high statistical significance (p < 0.001). The ERADICATE Hp study results demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105. Notably, subsequent open-label treatment with SoC therapies of patients in the placebo arm of the ERADICATE Hp study demonstrated only 63% eradication rate, further supporting the potential superior efficacy of RHB-105 over SoC.
RHB-105 was 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 U.S. market exclusivity, in addition to the standard exclusivity period, for a total of 8 years of U.S. market exclusivity.
The 2015 global and U.S. market potential for H. pylori eradication therapies at current branded prices, were estimated at approximately $4.83 billion and $1.45 billion, respectively, and could potentially grow with increasing awareness of the health risks associated with H. pylori infection and the benefits of its eradication.
