Shanghai-based drug development firm Hua Medicine, which focuses on developing global first-in-class oral drug for treating Type 2 diabetes, has recently announced that it has completed patient enrollment for a Phase III monotherapy trial of dorzagliatin (HMS5552). The company is expecting to release topline results from the study in the fourth quarter of 2019.

CEO of Hua Medicine, Dr. Li Chen, was quoted saying that this milestone takes the company one step closer to bringing dorzagliatin to the Chinese market, which consists of 120 million Type 2 diabetics.  The novel, first-in-class drug would be a 3^rd generation T2D drug, since it holds the potential to stop the progression of T2D, something which existing drugs have not been able to achieve, he said.

Dr. Chen added that the protocol follows the company’s Phase II study design, which provided strong efficacy and safety data along with promising disease modifying effects. Hua Medicine informed that the Phase III monotherapy registration trial would target patients who are drug naïve, which will position dorzagliatin as a first-line therapy. The trial is a placebo-controlled, double-blind study with patients being randomized 2:1 for receiving either placebo or dorzagliatin.

The clinical study would apparently evaluate the safety and efficacy of dorzagliatin with 24-week long double-blinded treatment plus 28 weeks of open-label treatment and follow-up. The study will be conducted at 40 clinical sites all over China, the company mentioned.

For the record, first-in-class glucokinase activator (GKA) dorzagliatin, is a drug designed for controlling diabetes’ progressive degenerative nature by restoring glucose homeostasis in Type 2 diabetics. Hua Medicine reportedly in-licensed dorzagliatin’s global rights from Roche.

Essentially, dorzagliatin has the potential to repair the impaired glucose homeostasis state in Type 2 diabetics by tackling the defect of the glucose sensor function of glucokinase, Hua Medicine stated. This can make the drug a first line standard of care therapy for treating patients with Type 2 Diabetes, or even as a cornerstone therapy to be applied in combination with existing anti-diabetes drugs which are approved.