RedHill Biopharma's ($RDHL) combo antibiotic for Helicobacter pylori infection met its main goal in a late-stage trial, putting the Israeli outfit in line for a sit-down with the FDA to plot a path to market.
The treatment, RHB-105, combines two antibiotics and a proton pump inhibitor to eradicate H. pylori, a pervasive bacterium that can cause chronic gastritis, peptic ulcer disease and gastric cancer. In a Phase III trial involving 118 H. pylori sufferers, two weeks of treatment with RedHill's pill led to an 89.4% cure rate, beating out the 70% historically found on standard therapy and meeting the study's primary endpoint.
There were no serious side effects or "unexpected safety issues" in the study, according to a RedHill statement. The company is disclosing only top-line data from the trial for now, expecting to present finalized results in the third quarter.
The news sent RedHill's shares up about 30% on Monday morning, as the biotech prepares to meet with U.S. regulators about a path forward for its top prospect. RedHill is planning to conduct a second Phase III study on RHB-105 and may need additional trials before filing for approval, depending on the FDA's feedback.
The agency has designated RHB-105 as a Qualified Infectious Disease Product, promising RedHill a speedy trip through the regulatory process and an additional 5 years of market exclusivity if it wins approval.
The biotech estimates the global market for H. pylori treatments at more than $4.8 billion a year, and RHB-105, if it keeps up the positive clinical results, could be well poised to carve out a major share of that, RedHill Senior Vice President Gilead Raday said in a statement.
Beyond its lead asset, RedHill is at work on RHB-104, a Phase III tablet for Crohn's disease; RHB-102, in late-stage development to treat gastroenteritis; and a handful of midstage drugs targeting a range of cancers. Alongside partner IntelGenx, RedHill is in the midst of an FDA reapplication with Rizaport, a migraine film rejected in 2014 over issues with a third-party manufacturer.
- read the statement