An International Multi-center Phase III Clinical Trial of Recombinant Human Neuregulin-1 is going to
After obtaining agreement from the FDA, Zensun is preparing to launch an international multi-center phase III clinical trial in the near future. The study will enroll patients in about 150 hospitals in 10 countries, including the US, China, and several European countries.
The trial is designed to be a randomized, parallel, placebo-controlled, double-blind, international multi-center registration study to evaluate the efficacy of Recombinant Human Neuregulin-1 in Chronic Heart Failure (CHF) subjects for improvements in a composite primary endpoint consisting of cardiovascular mortality and recurrent HF hospitalization. It is anticipated that the trial will be completed within about 2 years.
Data from previous studies by Zensun show that Recombinant Human Neuregulin-1 can reduce all-cause mortality in CHF patients, while also improving heart function (increasing LVEF), Quality of Life and exercise capacity and reducing the ventricular remodeling that causes CHF (decreasing LVESV and LVEDV).
The results from this study are expected to enable global Regulatory approvals and the eventual commercialization of Recombinant Human Neuregulin-1 in the worldwide market for the treatment of patients with Chronic Heart Failure.