RedHill planning NDA for H. pylori antibiotic following second Phase III readout

RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL) plans to submit an NDA to FDA next half for Talicia (RHB-105) as first-line treatment of Helicobacter pylori infection regardless of ulcer status after reporting that the antibiotic met the primary endpoint in the Phase III ERADICATE Hp2 trial in the indication.

Talicia is a fixed-dose oral combination of the antibiotics rifabutin and amoxicillin and the proton pump inhibitor (PPI) omeprazole. RedHill reported in 2015 that Talicia met the primary endpoint in the first Phase III trial to treat H. pylori infection (see "RedHill's Antibiotic Meets Phase III Endpoint")...