RedHill's antibiotic Talicia edges closer to approval, after second successful Phase III study
As one of the few companies focusing on tackling the burgeoning threat of superbugs, Israel’s RedHill Biopharma $RDHL is making strides. On Monday, it said its experimental drug Talicia was successful in eradicating the H. pylori infection, meeting the main goal of a second Phase III study.
The data are compelling enough for the company to submit an application to market the drug in 2019 for the estimated 2.5 million patients treated for the infection each year in the United States.
In the 455-patient trial, patients were either given Talicia or the active comparator, an amoxicillin and omeprazole regimen. Data showed an 84% eradication of H. pylori infection with Talicia versus 58% in those who got the other regimen.
Trial data also demonstrated patients experienced a high resistance to the standard-of-care regimen — consistent with the falling efficacy of such therapies, which typically consist of the antibiotics clarithromycin and metronidazole, the company said.
Talicia is an oral capsule comprising rifabutin, amoxicillin and a proton pump inhibitor, omeprazole.
About two-thirds of the world’s population has H. pylori in their bodies. But for most, it doesn’t cause ulcers or any other symptoms, though is considered the strongest risk factor for the development of gastric cancer.
The growing scourge of antibiotic resistance is a significant problem that should arguably entice a swarm of R&D dollars, but these drugs command relatively cheap prices and don’t last as long as, say, cancer drugs, which has incentivized Big Pharma 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 eligibility for six-month priority review and eight years of US market exclusivity. The product is also protected until at least 2034, under various US patents.