8:11 AM
 | 
Dec 03, 2018
 |  BC Extra  |  Clinical News

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").

The double-blind, U.S. ERADICATE Hp2 trial enrolled 455 dyspepsia patients with confirmed H. pylori infection to receive thrice-daily oral Talicia or equivalent doses of a dual combination therapy of amoxicillin and omeprazole for 14 days. On the primary endpoint, a significantly greater proportion of patients who received Talicia achieved eradication of their H. pylori infection at 43-71 days after initiation of treatment vs. amoxicillin and omeprazole (84% vs. 58%, p<0.0001). RedHill said no resistance to rifabutin was detected in the study.

The company hopes to launch Talicia, which has Fast Track and Qualified Infectious Disease Product (QIDP) designations from FDA, in 2H19.

RedHill was down $0.33 to $8.08 on NASDAQ on Monday; the company's shares added less than NIS0.01 to NIS3.15 in Tel Aviv.

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