ERADICATE Hp Phase III study with RHB 105 for the treatment of H. pylori infection meets primary endpoint- RedHill Biopharma
RedHill Biopharma has announced that the positive final results, announced in June 2015, of the first Phase III study with RHB 105 for the treatment of H. pylori infection were presented at the Innovations in Gastroenterology 2017 Symposium. RHB-105 is a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection. The ERADICATE Hp first Phase III study with RHB 105 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).>0.001).>
The study results demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105. Notably, the 89.4% efficacy in eradicating H. pylori infection with RHB 105 was also superior to subsequent open-label treatment with SoC therapies of patients in the placebo arm of the ERADICATE Hp study, which demonstrated only 63% eradication rate in the mITT population (p=0.006).
This data further supports the potential efficacy of RHB 105 as a treatment for H. pylori infection. Treatment with RHB 105 appeared to be safe and well tolerated. A confirmatory Phase III study with RHB 105 is planned to be initiated in the first half of 2017 after completion of an ongoing supportive pharmacokinetic (PK) program.
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