Hua Medicine, a leading clinical stage biotech company in Shanghai, announced the successful completion of its Phase II clinical trial for HMS5552, a novel 1st-in-class Glucokinase Activator (GKA) for the treatment of diabetes. The Proof-of-Concept clinical study was conducted in 22 leading hospital centers across China and was led by Professor Dalong Zhu, President-elect of the Chinese Diabetes Society.
The Phase II clinical trial was initiated exactly one year ago on September 22, 2015 with 258 Chinese Type 2Diabetes patients participating in the drug treatment study. In this double blind, placebo controlled, randomized Phase II study, patients received pre-specified oral doses of either active drug or placebo for 12 weeks with the goal of improving patients' HbA1c levels as the primary treatment end-point. Improvements in laboratory markers of plasma glucose control and beta-cell function were secondary end-points of the trial. The last patient out (LPO)milestone was achieved on August 17, 2016 and the company expects to present the data from the topline clinical efficacy and safety results by mid-October.
"We are very thankful for the incredible effort put forth by Hua's operational team, CRO and SMO partners, our scientific collaborators at all 22 academic institutions, and most of all our participating diabetes patients who made this trial possible," said Dr. Li Chen, CEO of Hua Medicine. "HMS5552 is one of the first 1st-in-classdrugs developed entirely in China for a major disease indication such as diabetes, and the completion of this Phase II trial marks a major milestone in accelerating drug-development innovation in China. We are proud to play a part in this continuing evolution and are eager to present our topline data in October."