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 …
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.
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