Chinese clinical stage biotech company Hua Medicine has reported positive results from its Phase II monotherapy trial of HMS5552 to treat diabetes.
HMS5552 is the company’s fourth-generation glucokinase activator, which targets one of the important enzymes posing as a glucose sensor and controlling the pathways for carbohydrate metabolism.
The Phase II monotherapy trial was undertaken as a multicentre, randomised, double-blind, placebo-controlled, parallel five-dose arm study, which involved 258 Type 2 Diabetes patients.
The patients were administered with HMS5552 and placebo over a period of 12 weeks, following a standardised four-week placebo run-in period.
Results suggested the efficacy of HMS5552 in addressing diabetes, while exhibiting tolerability and safety profile with low risk of hypoglycemia or other associated side effects.
Hua Medicine clinical research and development vice-president Dr Yi Zhang said: "We are very thankful for the incredible effort put forth by Hua's operational team, CRO and SMO partners, our physician collaborators at all 22 hospital centres, and all of our participating diabetes patients who made this trial possible.
"The excellent results of our clinical studies are a testament to our team's adherence to the highest international standards of quality control that always places patient health and safety as primary goals."
According to Hua Medicine CEO Dr Li Chen, subject to regulatory authority approvals, the company is planning to begin the Phase III pivotal studies of HMS5552 next year.