SHANGHAI, China, June 15, 2020 (GLOBE NEWSWIRE) -- Hua Medicine (the “Company”, Stock Code: 2552. HK), a leading innovative drug development company focused on developing novel therapies for the treatment of diabetes, announced post-analysis results from dorzagliatin’s 24-week monotherapy trial SEED, (also known as HMM0301).
The following findings from the SEED study were presented in oral and symposium presentations at the American Diabetes Association’s 80th Scientific Session digitally:
- Fast on-set of action (effective HbA1c reduction in 4 weeks)
- Significant improvement of β-cell function in treatment group as compared to the placebo group
- Significant reduction of 2-hour post-prandial glucose reduction was observed in treatment group as compared to the placebo group
- Good safety profile and tolerance of dorzagliatin with limited hypoglycemia and similar incidence of adverse events between the treatment and placebo groups
- Sustained efficacy over 24 weeks
- Good response rate
“The post-analysis dorzagliatin data builds upon the positive results from our topline results,” said Dr. Li Chen, CEO and CSO of Hua Medicine. “The results demonstrate dorzagliatin’s potential to restore glucose homeostasis in Type 2 diabetes patients, and continue to support our efforts to launch dorzagliatin as a cornerstone therapy for the treatment of Type 2 diabetes.”
Dorzagliatin shows improvements in marker that measure β-cell function
Data demonstrates that there was significant β-cell function improvement (as measured by HOMA2-β1) in the treatment group versus the placebo group – an increase of 2.56% vs. a decline of 0.72% in β-cell function improvement.
In the trial, Dorzagliatin exhibits positive impact on blood glucose control with a good safety profile
The post-analysis of Phase III monotherapy results show that dorzagliatin exhibits several promising characteristics for Type 2 diabetes treatment.
- Dorzagliatin achieved a statistically significant reduction of blood glucose - 1.07% reduction in HbA1c from baseline
- Significant 2-hour post-prandial glucose reduction was observed (-2.83mmol/L vs -0.50mmol/L, p<0.001)
- Patients saw fast on-set of blood glucose reduction during the first follow-up visit after initiation of treatment
- Hypoglycemia was very mild (1 incidence out of 310 patients in the treatment group over 24-week period)
- Other incidences of adverse events were similar between the treatment and placebo groups
Note 1: The HOMA, Homeostatic Model Assessment, is a computer model to evaluate the beta cell function and insulin resistance in clinical studies that was developed in 1985. It is used to estimate the insulin sensitivity and beta cell function based on fasting glucose and insulin or c-peptide. HOMA2 is a computer model advance from HOMA1 and includes the factors of hepatic and peripheral insulin resistance, a physiological measure of glucose homeostasis.
Source: Diabetes Care 2004, 27(6), 1487
About Dorzagliatin
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 Diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired glucose homeostasis state of patients with Type 2 Diabetes and serve as a first-line standard-of-care therapy for the treatment of the disease, 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 developing 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 is currently evaluating the therapy in adults with diabetes in two Phase III trials in China and various earlier stage clinical trials in China and the United States. Dorzagliatin has achieved its first primary endpoint in a Phase III monotherapy trial. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.