RedHill's antibiotic meets Phase III endpoint

RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL) gained $2.61 (16%) to $19.07 after it said RHB-105 met the primary endpoint of superiority over historical standard of care in the Phase III ERADICATE Hp study to treat Helicobacter pylori infection. Current SOC is a triple therapy including amoxicillin, clarithromycin and a proton pump inhibitor.

Patients receiving RHB-105 had a cure rate of 89.4%, compared to a historical 70% efficacy rate for SOC (p<0.001). The study included 118 dyspepsia patients with confirmed H. pylori infection randomized to receive either RHB-105 or placebo for 14 days. No serious adverse events were reported. RedHill said it expects full study results by 3Q15, and hopes to meet with FDA by YE15 to discuss its regulatory strategy. The company is planning a second Phase III trial and is pursuing approval of RHB-105 as first-line treatment of H. pylori infection regardless of ulcer status. ...