FDA grants QIDP Fast-Track designation to RedHill Biopharma's H. pylori drug

TEL-AVIV, Israel— With half of the targeted 120 patients already recruited, top-line data from the ongoing RHB-105 first Phase 3 study in the U.S. is expected in the second quarter of 2015, noted RedHill Biopharma Ltd., in its announcement that its Phase 3 Helicobacter pylori (H. pylori) eradication therapy, RHB-105, has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration (FDA). The QIDP designation has been granted under the FDA's Generating Antibiotic Incentives Now (GAIN) act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections. H. pylori, a major cause of chronic gastritis, peptic ulcer disease and gastric cancer, has recently been added by the FDA to the list of qualifying pathogens that have the potential to pose a serious threat to public health.

The granted QIDP designation allows RedHill to benefit from Fast-Track development status with an expedited development pathway for RHB-105 and Priority Review status, which provides for a shorter review time by the FDA of a future potential marketing application. If approved, RHB-105 will also receive an additional five years of U.S. market exclusivity on top of the standard exclusivity period.

Gilead Raday, RedHill's senior vice president, corporate and product development, said: "We are very pleased to have received the QIDP designation for RHB-105 by the FDA. The growing resistance rates of H. pylori to existing antibiotic therapies pose significant challenges to health organizations worldwide and the recent addition of H. pylori to the list of qualifying pathogens under the FDA's GAIN Act highlights the need for new therapeutic alternatives to treat H. pylori infected patients. RHB-105 is a new and proprietary all-in-one triple combination oral therapy which has demonstrated promising results in a Phase 2 study, and we hope to repeat these results in the ongoing Phase 3 study. The QIDP designation granted by the FDA provides important recognition of the potential of RHB-105 to address unmet needs in the treatment of H. pylori infection and we believe it will help accelerate the development process, potentially allowing patients faster access to the drug. We are pleased with the progress in the ongoing RHB-105 first Phase 3 study and expect top-line data in the second quarter of 2015." 

RHB-105 is a proprietary fixed-dose combination therapy of two antibiotics and a proton pump inhibitor (PPI). PPIs are a group of drugs whose main action is a pronounced and long-lasting reduction of gastric acid production and are considered the most potent inhibitors of acid secretion available. The combination is provided in an all-in-one oral capsule, specifically selected due to the potential for improved efficacy and a superior resistance profile in eradicating H. pylori infection. RHB-105 is currently undergoing a Phase 3 clinical study in the U.S. for the treatment of H. pylori infection (the ERADICATE Hp study) following a successful Phase 2 study in Australia which demonstrated eradication rates exceeding 90 percent in 130 subjects.

RedHill is pursuing a significantly broader indication with RHB-105 targeting H. pylori infection as a first line treatment regardless of ulcer status, while current standard treatments for the infection are typically indicated to treat H. pyloriatients with active or a recent history of ulcers. If approved, RHB-105 may be the first H. pylori eradication therapy to pursue this broader indication, which would significantly expand the potential patient population for the drug. 

It is estimated that approximately two-thirds of the world's population is infected with H. pylori, a bacterial infection which is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma. Over three million patients are treated annually in the U.S. to eradicate the infection. Redhill estimates the potential market of H. pylori eradication therapies in the U.S. at approximately $1-1.5 billion annually. 

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 treatment of H. pylori infection. The RHB-105 combination was originally developed as a next-generation therapy by Prof. Thomas Borody, a leading innovator of therapeutic approaches to gastrointestinal tract diseases, who developed the first approved triple therapy treatment for H. pylori associated with peptic ulcer disease.

RedHill Biopharma Ltd. is an emerging Israeli biopharmaceutical company focused on the development and acquisition of late clinical-stage, proprietary drugs for the treatment of inflammatory and gastrointestinal diseases, including gastrointestinal cancers. In addition to RHB-105, RedHill's current pipeline of proprietary products includes: RHB-104, an oral combination therapy for the treatment of Crohn's disease, with an ongoing first Phase 3 study; RHB-102, a once-daily oral pill formulation of ondansetron with a Phase 3 study in the U.S. for acute gastroenteritis and gastritis and a planned European marketing application for chemotherapy and radiotherapy-induced nausea and vomiting; RHB-106, an encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals, Ltd.; MESUPRON®, a Phase 2 stage µPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumor cancers; RP101, currently subject to an option-to-acquire by RedHill, a Phase 2-stage Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers; RIZAPORT® (formerly RHB-103), an oral thin-film formulation of rizatriptan for acute migraines with a U.S. NDA currently under discussions with the FDA and a European marketing application submitted in October 2014; and RHB-101, a once-daily oral pill formulation of the cardio drug carvedilol.