As resistance to standard antibiotics grows, RedHill's H. pylori regimen secures FDA approval
In 2017, the WHO designated clarithromycin-resistant H. pylori, a bacterial infection that affects more than half of the global population, a high priority for antibiotic research and development. On Monday, Israel’s RedHill Biopharma secured FDA approval for its rifabutin-based regimen to address the alarming rates of resistance to standard-of-care therapies.
The new drug will be marketed as Talicia, and the company says it plans a launch in the first quarter of 2020. The therapy is an oral capsule comprising rifabutin, amoxicillin and a proton pump inhibitor, omeprazole, and was tested in two late-stage trials, ERADICATE Hp and ERADICATE Hp2.
Shares of the drugmaker $RDHL jumped about 15.6% to $8 premarket on Monday.
In the ERADICATE Hp study, Talicia, showed 89.4% efficacy in eradicating H. pylori infection, surpassing the historical standard-of-care efficacy levels of 70%.
In the confirmatory ERADICATE Hp2 trial, Talicia was tested against an active comparator therapy — an amoxicillin and omeprazole regimen. Data showed an 84% eradication of H. pylori infection with Talicia versus 58% in those who got the other treatment. Trial data also demonstrated patients experienced a high resistance to the standard-of-care — consistent with their deteriorating efficacy — the company said when it published the results last December.
“Studies with Talicia found zero resistance to rifabutin and showed 17% resistance to clarithromycin, a current standard-of-care macrolide antibiotic, consistent with current data showing that clarithromycin-containing therapies fail in approximately 25-40% of cases,” said David Graham, lead investigator of the Talicia phase III studies, in a statement.
About two-thirds of the world’s population have H. pylori in their bodies. But for most, it doesn’t cause ulcers or any other symptoms. However, it is a major cause of peptic ulcer and gastritis and is considered the strongest risk for gastric cancer. About 35%, or over 100 million people, in the United States are infected, with an estimated 2.5 million patients treated annually in the region.
The growing scourge of antibiotic resistance is a global issue that should arguably entice a swarm of R&D dollars, but these drugs command relatively cheap prices and do not offer a rich reimbursement, like cancer drugs, which has incentivized most big pharmaceutical companies to focus their attention elsewhere. However, a handful of small and big names are keeping the R&D engine hot. Tel Aviv’s Redhill is one of them, and the FDA has rewarded their dogged focus by giving Talicia all the bells and whistles to hasten its path toward approval.
The drug was granted the Qualified Infectious Disease Product designation as well as fast-track status by the regulator, including a six-month priority review and eight years of US market exclusivity. The product is also protected until at least 2034, under various US patents.