The Food and Drug Administration has granted Qualified Infectious Disease Product (QIDP) designation to the oral drug RHB-105 as first-line treatment for patients with Helicobacter pylori (H. pylori) infection regardless of ulcer status. H. pylori is a known cause of gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma, as well as chronic gastritis and peptic ulcer disease.
This indication for RHB-105 is significantly broader than current standard treatments for H. pylori, which are typically indicated to treat patients with an active or a recent history of ulcers, according to a news release from the drug manufacturer, RedHill Biopharma Ltd.
The FDA's QDIP designation, established under the Generating Antibiotic Incentives Now (GAIN) Act, is intended to encourage the development of new antibiotic drugs for the treatment of serious or life-threatening infections. The designation also gives the drug Fast-Track development status, Priority Review of a potential future New Drug Application, and an additional five years of exclusivity for the product, if the drug is approved.
H. pylori was recently added by the FDA to the Agency's list of qualifying pathogens that have the potential to pose a serious threat to public health, which was also established under the GAIN Act. In addition to H. pylori increasing risk of ulcers and other gastric diseases, research suggests that some 35 to 60 percent of gastric adenocarcinomas are attributable to H. pylori infection; and H. pylori is estimated to be responsible for approximately two-thirds of gastric lymphomas (Clinical and Translational Gastroenterology 2013;4:e32).
RHB-105, a fixed-dose combination therapy of two antibiotics and a proton pump inhibitor, is currently undergoing Phase III clinical testing in the U.S. Data from Phase II studies in Australia showed the drug had eradication rates that exceeded 90 percent.