- The Food and Drug Administration has approved the chemistry, manufacturing and controls (CMC) protocol laid out by RedHill Biopharma for its stomach illness drug, the company said in a Thursday statement.
- The drug in question, RHB-105, is a treatment for infection from the bacteria H. pylori. Though such infections can be harmless, they have also been known to cause ulcers and gastritis in the digestive tract and stomach.
- RedHill has a Phase 3 confirmatory trial for RHB-105 scheduled for the first half of 2017. The Israel-based company expects the study — along with its pharmacokinetics program and positive clinical data from previous trials — to solidify its approval status.
The FDA's nod to RedHill's CMC plan is important for the company's pipeline, especially for its gastrointestinal and inflammation products.
The company only has two products that have made it through clinical trials: Bekinda, an anti-nausea and vomiting treatment similar to GlaxoSmithKline's Zofran that is up for approval in Europe, and Rizaport, a migraine drug co-developed with Canada's IntelGenx.
As such, laying the groundwork for commercializing products in the U.S. is a priority, according to the company's most recent quarterly financial report.
“With a strong cash position of $47.7 million at the end of the second quarter we are well-positioned to advance our strategic and operational plans, including the establishment of commercial operations in the U.S.," RedHill CEO Micha Ben Chorin said in the report. "During the second quarter, we continued to actively advance our three Phase III-stage gastrointestinal programs."
Should RedHill's drug get approved, it would find itself in a growing market. A BCC Research report published in September found the global gastrointestinal disorder and diagnostics market reached nearly $50 billion in 2015, and projected the market would hit $63.8 billion this year, with a 4.3% compound annual growth rate through 2021.
The FDA labeled RHB-105 a "qualifying infectious disease product," meaning it has been fast tracked and given priority review for any new drug application submitted.
The Phase 3 study will enroll about 440 patients across as many as 55 U.S. locations, according to the Nov. 10 statement. In a previous Phase 3 study, RHB-105 was shown to cure H. pylori infection in almost 90% of patients.