RedHill Biopharma Announces Enrollment of 300th Patient in Confirmatory Phase III Study with TALICIA® for H. pylori Infection
- Approximately 70% of the planned total of 444 patients have been enrolled in the ongoing confirmatory U.S. Phase III study with TALICIA® for H. pylori infection (ERADICATE Hp2)
- RedHill expects to complete enrollment in Q3/2018 and announce top-line results in Q4/2018
- The study is expected to complete the package required for filing a U.S. NDA for TALICIA® in early 2019, subject to a successful outcome and regulatory feedback. If accepted, the NDA will benefit from priority review of 6 months with potential
FDAapproval in H2/2019
- 2015 worldwide and U.S. markets for H. pylori eradication therapies estimated at approximately
$4.83 billionand $1.45 billion, respectively
- The first U.S. Phase III study with TALICIA® successfully met its primary endpoint with high statistical significance (p<0.001), demonstrating 89.4% efficacy in eradicating H. pylori infection. These results were also superior to subsequent open-label treatment with standard-of-care (SoC) therapies which demonstrated only 63% eradication rate (p=0.006), further supporting the potential superior efficacy of TALICIA® over current SoC therapies
RedHill remains on track to potentially complete enrollment of the ERADICATE Hp2 study in the third quarter of 2018 and expects to announce top-line results in the fourth quarter of 2018.
TALICIA® was granted QIDP (Qualified Infectious Disease Product) designation by the
The two-arm, randomized, double-blind, active comparator, confirmatory Phase III study was designed to enroll 444 non-investigated dyspepsia patients with confirmed H. pylori infection at up to 65 clinical sites in the U.S.. The primary endpoint is eradication of H. pylori infection at 43 through 71 days after initiation of treatment.
Subject to a successful outcome and additional regulatory feedback, the ERADICATE Hp2 study is expected to complete the package required for a potential U.S. NDA for TALICIA®. The filing is planned for early 2019 and, if accepted for review, the
The ERADICATE Hp2 confirmatory Phase III study with TALICIA® (RHB-105) is registered on www.ClinicalTrials.gov, a web-based service of the
The first Phase III study with TALICIA® (ERADICATE Hp study) successfully met its protocol-defined mITT primary endpoint of superiority over historical standard-of-care (SoC) eradication rate of 70%, with high statistical significance (p<0.001). The study results demonstrated 89.4% efficacy in eradicating H. pylori infection with TALICIA®. Notably, the 89.4% efficacy in eradicating H. pylori infection with TALICIA® was 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 in the mITT population (p=0.006), further supporting the potential efficacy of TALICIA®. Treatment with TALICIA® appeared to be safe and well tolerated.
About H. pylori
H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma and is estimated to affect over half of the adult population worldwide2.
The 2015 worldwide and U.S. markets for H. pylori eradication therapies were estimated at approximately
About TALICIA® (RHB-105):
TALICIA® (RHB-105) is a new and proprietary fixed-dose oral combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule with a planned indication for the treatment of H. pylori infection. H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. A first Phase III study with TALICIA® (ERADICATE Hp study) was completed in the U.S. with positive results. The study demonstrated an overall success rate of 89.4% in eradicating H. pylori and met its protocol-defined primary endpoint of superiority in eradication of H. pylori infection over historical standard-of-care efficacy levels of 70%, with high statistical significance (p<0.001). A confirmatory Phase III study (ERADICATE Hp2 study) is ongoing in the U.S. Additional studies may be required, subject to
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Senior VP Business Development & Licensing
1 TALICIA® (RHB-105) is an investigational new drug, not available for commercial distribution.
2 Hunt, R. H., et al. "Helicobacter pylori in developing countries." World Gastroenterology Organisation Global Guidelines (2010): 1-15.
Source: RedHill Biopharma Ltd.