RedHill Biopharma announced that the last patient was enrolled in the confirmatory Phase III study with TALICIA 1 for H. pylori infection. Top-line results from the study are expected to be announced before year’s end.If successful, and subject to additional regulatory feedback, the ERADICATE Hp2 study is expected to complete the package required to file a New Drug Application with the U.S. FDA for TALICIA in early 2019. TALICIA was granted Qualified Infectious Disease Product designation by the FDA, providing Fast-Track Development, six months priority NDA review and eight years of U.S. market exclusivity. TALICIA is intended to be the first product to be indicated for the treatment of H. pylori infection, regardless of ulcer status. The two-arm, randomized, double-blind, active comparator confirmatory Phase III study compares TALICIA against a dual therapy amoxicillin and omeprazole regimen at equivalent doses. The study enrolled 455 non-investigated dyspepsia patients with confirmed H. pylori infection in 55 clinical sites across the U.S. Subjects were randomized in a 1:1 ratio to receive four capsules, three times daily, of either TALICIA or the active comparator, for a period of 14 days. Subjects are being assessed for the study’s primary endpoint of eradication of H. pylori infection at 43 through 71 days after initiation of treatment. The first Phase III study with TALICIA successfully met its primary endpoint of superiority over historical standard-of-care eradication rate of 70%, with high statistical significance. The study results demonstrated 89.4% efficacy in eradicating H. pylori infection with TALICIA. Notably, these results were also superior to subsequent open-label treatment with SoC therapies of patients in the placebo arm of the ERADICATE Hp study, which demonstrated 63% eradication rate, further supporting the potential efficacy of TALICIA. Treatment with TALICIA was shown to be safe and well tolerated.
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