February 02 2019, Shanghai
Hua Medicine (“Hua” or “the Company”; Stock Code: 2552.HK) a Shanghai-based drug development company focused on developing a global first-in-class oral drug for the treatment of Type 2 diabetes (T2D), announced today dosing of the first patient in a clinical trial of HMS5552 (dorzagliatin) in patients with insufficiently controlled blood glucose levels with metformin, DPP-4 inhibitor, or SGLT-2 inhibitor, alone or in combination therapy. The trial is a pharmacokinetic (PK) and pharmacodynamic (PD) study of dorzagliatin in combination with sitagliptin to investigate the PK/PD of each drug alone or in combination. The primary endpoints are pharmacokinetic and pharmacodynamic interaction between dorzagliatin and sitagliptin, and safety and tolerability of dorzagliatin with simultaneous administration of sitagliptin. This trial is conducted in the United States.
“Current T2D treatment follows medical practices guidelines and addresses patients as if they are the same,” said Dr. Li Chen, Chief Executive Officer of Hua Medicine. “With 435 million T2D patients globally, it is important to classify Type 2 diabetics to provide tailored prescriptions that result in better efficacy, improved safety, and reduced complications. The clinical study of dorzagliatin with DPP-4 inhibitor allows us to validate the synergy of both mechanisms of action, and take the next step in establishing dorzagliatin as a cornerstone therapy for T2D.”
There are 435 million individuals with T2D globally, with a diagnosis rate of 54.2%. Diabetes imposes a large economic burden on the global healthcare system, costing US$850 billion globally in 2017. Currently approved diabetes therapies cannot effectively control the progression of diabetics into more advanced stages of the diseases, which then leads to the many complications associated with severe diabetes, such as loss of vision, peripheral neuropathy, impaired kidney function, cardiovascular disease, and stroke.
Dorzagliatin is a first-in-class glucokinase activator, or GKA, designed to control the progressive degenerative nature of diabetes by restoring glucose homeostasis in Type 2 diabetics. By addressing the defect of the glucose sensor function of glucokinase, or GK, dorzagliatin has the potential to repair the impaired glucose homeostasis state of T2D and serve as a first-line standard of care therapy for the treatment of Type 2 diabetes, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs.
About Hua Medicine
Hua is a leading, clinical stage innovative drug development company in China focused on novel therapies for the treatment of diabetes. Founded by an experienced group of entrepreneurs and international investment firms, Hua advanced a first-in-class oral drug for the treatment of Type 2 Diabetes into NDA enabling stage and started 2 Phase 3 trials in China for drug naive and metformin treated T2D patients. The company also has initiated product life-cycle management studies of this novel diabetes drug, and advanced its potential use in personalized diabetes care. Hua's strategy is to leverage the cost-efficient and high-quality drug development capabilities available in China, while working very closely with disease experts in China and rest of world to advance diabetes care solutions for global patients.
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