Exciting results from the Neucardin™ Phase III clinical trial (Interim Analysis)
Injectable Recombinant Human Neuregulin-1(Neucardin™) is an innovative genetic engineering biologic product developed by Zensun (Shanghai) Sci & Tech Co. Ltd. for treatment of mild to moderate chronic heart failure (CHF). Zensun launched its phase III clinical trial (project ZS-01-305) in 2012 to evaluate the efficacy of Neucardin™ on mortality rate reduction in target patients, and has enrolled 679 patients as of the Interim analysis. On February 2016, Zensun authorized PAREXEL China Co. Ltd. to initiate the interim analysis of this trial, whose statistical results were released to Zensun on June 5, 2017.
The results reveal that based on the clinical standard therapy, Neucardin™ reduced one-year all-cause mortality (the primary endpoint) by 17% compared with placebo in mild to moderate CHF patients. Further subgroup analysis based on the heart failure biomarker NT-proBNP revealed that for patients with a baseline NT-proBNP of less than 1600 fmol/mL (about 60% of total subjects), Neucardin™ significantly reduced their all-cause mortality by at least 60%. This result is consistent with the results of a previous Neucardin™ clinical trial, ZS-01-209 (351 patients), obtained in 2012. Such an improvement in reducing mortality rates in heart failure patients has rarely been seen during the global quest for developing heart failure drugs. Combining the data of this clinical trial with the previous ZS-01-209 and ZS-01-301 trials, statistical analysis indicates that Neucardin™ could reduce the one-year all-cause mortality of target patients by 62%. Target patients are those classified as NYHA II/III degree and with a baseline NT-proBNP of less than 1600 fmol/mL. These three clinical trials have enrolled 1361 patients in total, with 643 target patients that include over 300 patients each in placebo and administration groups.
Zensun will use the statistical results obtained to review and revise the ongoing clinical trials, to support the following implementing of clinical trials and new drug approval. As further commercialization of this novel biologic has promising benefits to CHF patients worldwide.