rhNRG-1 Phase II Clinical study Showed a Significant Decrease of Rehospitalization
2009-11-20
A year after the phase II clinical trial with rhNRG-1 acute treatment, Zensun conducted follow-up and rehospitalization rate statistics. The results showed that the rehospitalization rate of rhNRG-1 group is only 0.17 per person. Compared to rehospitalization rate of placebo group (0.37 per person), rehospitalization rate decreased 53% (p＜0.038). This significant difference between two groups.
The previous phase II clinical trials show that cardiac function was effectively improved in the middle dose group: LVEF increased by 27.11% (p<0.049). Results demonstrated that rhNRG-1 could significantly decrease of LVESV and effective ventricular remodeling. increases cardiac function, reversed ventricular remodeling, and reduced circulating NT-proBNP levels (an independent long-term prognostic factor).
So far, Zensun’s propriety anti-heart failure drug—rhNRG-1 has confirmed its safety and efficacy. Moreover, SFDA has recognized the rehospitalization rate as a clinical endpoint for heart failure drugs approval. With rehospitalization rate data of rhNRG-1, Zensun expects a bright prosperity of phase III clinical study.
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