RedHill Biopharma Announces Completion of Enrollment for Confirmatory Phase III Study with TALICIA for H. pylori Infection

RedHill Biopharma (Nasdaq:RDHL) a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, today announced that the last patient was enrolled in the confirmatory Phase III study with TALICIA (RHB-105)1 for H. pylori infection (ERADICATE Hp2 study).

As quoted in the press release:

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 (NDA) with the U.S. Food and Drug Administration (FDA) for TALICIA^® in early 2019.

TALICIA^® was granted Qualified Infectious Disease Product (QIDP) 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.

Click here to read the full press release.