TEL-AVIV, Israel—RedHill Biopharma Ltd., a biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally administered, small molecule drugs for inflammatory and gastrointestinal diseases, including cancer, today announced additional supportive data from the first Phase 3 study with RHB-105 for eradication of H. pylori (the ERADICATE Hp Study). Results from the subsequent open-label treatment of patients in the placebo arm with standard-of-care (SoC) therapy for persistent H. pylori infection demonstrated a 63 percent eradication rate with SoC, compared to the 89.4 percent eradication rate demonstrated in the RHB-105 arm of the controlled study.
These results further support the potential superior efficacy of RHB-105 over SoC and validate the use of the historical SoC efficacy threshold of 70 percent implemented in the ERADICATE Hp study as the control for the study's primary endpoint. RedHill announced in June 2015 positive top-line results from the ERADICATE Hp Phase 3 study for the treatment of H. pylori bacterial infection. The top-line results demonstrated 89.4 percent efficacy in eradicating H. pylori infection with RHB-105. The study successfully met its primary endpoint of superiority over historical SoC eradication rate levels of 70 percent, with high statistical significance (p<0.001). No serious adverse events related to the drug product, new or unexpected safety issues were identified in the study.
Gilead Raday, RedHill's senior VP corporate and product development, commented: "The positive top-line results from the first Phase 3 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. We plan to meet with the FDA during the fourth quarter of 2015 or the first quarter of 2016 to discuss the future development plan of RHB-105 and the path to marketing approval of this important drug candidate in the U.S."
The 2015 global and U.S. market potential for H. pylori eradication therapies, at current branded prices, were recently 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.
Prof. David Graham, M.D., M.A.C.G., of the Baylor College of Medicine, a key opinion leader in the field of gastric cancer and H. pylori infection and principal investigator of the ERADICATE Hp Study, said: "The study's results of 63 percent eradication rate of H. pylori infection with standard-of-care (SoC) 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. Furthermore, it strengthens the RHB-105 Phase 3 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, and the falling cure rates of SoC therapies represent a significant concern for healthcare authorities worldwide. Despite existing therapies becoming increasingly ineffective in eradicating H. pylori, no new therapies have been approved for this indication in the last decade."
The randomized, placebo-controlled, ERADICATE Hp Phase 3 study was intended to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed H. pylori bacterial infection. A total of 118 non-investigated dyspepsia patients with confirmed H. pylori infection were enrolled and treated in the study, which was conducted in the U.S. Subjects were randomized in a 2:1 ratio to receive either RHB-105 or a placebo for a period of 14 days and assessed for the eradication of the infection. Subsequent to completion of the treatment period and the un-blinding of the study, subjects enrolled in the placebo arm were entitled to receive SoC therapy as prescribed by the treating physician in an open-label setting, and were assessed for the eradication of H. pylori infection 28-35 days after completion of treatment.
RedHill recently entered into an agreement with Recipharm AB, a leading contract manufacturing organization, for the manufacture of RHB-105. Under the terms of the agreement, Recipharm will be responsible for manufacturing RHB-105 for the planned second Phase 3 study and for future potential commercial supply of RHB-105. In order to support the manufacturing of RHB-105, Recipharm will invest approximately 13 million SEK (approximately $1.55 million) in manufacturing capabilities. Recipharm operates development and manufacturing facilities with approximately 2,200 employees in Sweden, France, the UK, Germany, Spain, Italy and Portugal and is headquartered in Jordbro, Sweden.
Top-line and other results from the ERADICATE Hp Phase 3 study, demonstrating achievement of primary endpoint, were provided to RedHill by an independent third party following an independent analysis and remain subject to completion of the independent review and analysis of the underlying data, including all safety, secondary and other outcome measures. Completion of the clinical study report is expected in the fourth quarter of 2015.
RHB-105 is a new and proprietary fixed-dose oral combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule with a planned indication for the treatment of H. pylori infection, which is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma. RedHill plans to conduct a second Phase 3 study. Additional studies may be required, subject to FDA feedback. 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 an NDA, 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 market exclusivity.
RedHill Biopharma Ltd. is an emerging Israeli biopharmaceutical company primarily focused on the development of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of inflammatory and gastrointestinal diseases, including gastrointestinal cancers. RedHill's current pipeline of proprietary products includes: (1) RHB-105—an oral combination therapy for the treatment of Helicobacter pylori infection with successful top-line results from a first Phase 3 study; (2) RHB-104—an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase 3 study; (3) BEKINDA (RHB-102)—a once-daily oral pill formulation of ondansetron with an ongoing Phase 3 study in the U.S. for acute gastroenteritis and gastritis and a European marketing application for chemotherapy and radiotherapy-induced nausea and vomiting submitted in December 2014; (4) RHB-106—an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (5) YELIVA (ABC294640)—an orally administered first-in-class SK2 selective inhibitor targeting multiple inflammatory, gastrointestinal and oncology indications with a Phase 1/2 study initiated for refractory/relapsed diffuse large B-cell lymphoma (DLBCL); (6) MESUPRON—a Phase 2-stage first-in-class µPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumor cancers; (7) RP101—currently subject to an option-to-acquire by RedHill, RP101 is a Phase 2-stage first-in-class Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers; (8) RIZAPORT (RHB-103)—an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA currently under discussion with the FDA and a European marketing application submitted in October 2014; and (9) RHB-101—a once-daily oral pill formulation of the cardio drug carvedilol.