• Phase III Monotherapy Trial (HMM0301) of Dorzagliatin Achieves Primary Efficacy Endpoint with 24-Week Topline Results
  • First Phase III trial of a therapy targeting the underlying cause of type 2 diabetes by restoring glucose homeostasis through modulation of the glucose-sensor glucokinase
  • Dorzagliatin was well tolerated and had a good safety profile: Fewer than 1 percent of patients experienced any incidence of hypoglycemia over 24 weeks, and  patients treated with dorzagliatin experienced no drug-related serious adverse events
  • Achieves HbA1c reduction of 1.07 percent from baseline at 24 weeks with p-value less than 0.0001
  • First instance of a China-based biotech company achieving primary efficacy endpoint for a global first-in-class drug candidate in type 2 diabetes

SHANGHAI, China, Nov. 11, 2019 (GLOBE NEWSWIRE) -- Hua Medicine (Stock Code: 2552.HK) today announced 24-week top-line results from HMM0301 [NCT03173391], the first Phase III trial of a novel first-in-class dual-acting glucokinase (GK) activator, dorzagliatin (HMS5552), which was designed to restore glucose homeostasis in adults with type 2 diabetes. Hua Medicine is currently conducting two pivotal 52-week Phase III trials in China (dorzagliatin as a monotherapy and in combination with metformin), each with an initial 24-week double blinded, placebo-controlled treatment, followed by an open label 28-week treatment in which all patients receive dorzagliatin. In this HMM0301 trial, Chinese drug-naïve Type 2 diabetes patients received 75 mg of dorzagliatin or placebo (randomized 2:1) twice per day and were monitored every four weeks during the first 24-weeks for efficacy and safety outcomes.  The subsequent 28-week treatment period is ongoing.

The trial achieved its primary efficacy endpoint by demonstrating a statistically significant reduction in HbA1c levels over placebo during the first 24 weeks of the trial. Patients treated with dorzagliatin achieved 1.07 percent HbA1c reduction from baseline of 8.35 percent at 24 weeks compared to a reduction of 0.50 percent from a baseline of 8.37 percent in patients who received placebo (Least square mean, p-value less than 0.0001). The American Diabetes Association (ADA) treatment target of HbA1c below 7.0 percent was achieved by 45.4 percent of subjects on dorzagliatin (PPS data, p-value less than 0.0001), compared to 21.5 percent of subjects who received placebo. The homeostatic control rate, measured by the percentage of Type 2 diabetes patients who achieved an HbA1c level of below 7.0 percent without hypoglycemia, reached 45.0 percent in subjects on dorzagliatin (PPS data, p-value less than 0.0001), and 21.5 percent in subjects on placebo.

Consistent with the findings from our Phase II trial, which were published in The Lancet Diabetes and Endocrinology on May 4, 2018, dorzagliatin exhibited a safe and well-tolerated clinical profile during the 24-week period. Fewer than 1 percent of patients experienced clinically significant hypoglycemia1 and no severe hypoglycemia2 was reported, based on the ADA’s guidelines. A safety analysis based on study safety population demonstrated that dorzagliatin was well tolerated and had a good safety profile.The incidence of adverse events was similar between the dorzagliatin-treated and placebo groups. The majority of the adverse events were mild in severity. No deaths and no drug-related serious adverse events were reported by investigators in the dorzagliatin-treated group.

“These initial results bring us one step closer to treating type 2 diabetes with a novel oral treatment that has the potential to address the primary cause of the disease by repairing glucose sensors and restoring glucose homeostasis,” said Dr. Zhu Dalong, leading principal investigator of HMM0301, Director of Endocrinology at the Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, and President of the Chinese Diabetes Society. “Dorzagliatin provides an opportunity to treat diabetes by remodeling the endocrine functions of the pancreas, liver and intestine, which augment glucose homeostasis through regulation of insulin, glucagon and GLP-1 secretion. We are very pleased at the success of dorzagliatin’s clinical development, which may offer a novel treatment paradigm for Type 2 diabetes patients.”

“We are very excited by the results of the dorzagliatin monotherapy trial, which represents the first time that a clinical study has demonstrated that a dual-acting glucokinase activator can be a viable, effective, and safe option for the treatment of type 2 diabetes,” said Dr. Chen Li, CEO, CSO and founder of Hua Medicine. “Hua Medicine has developed dorzagliatin to stop diabetes by using a therapeutically minimum effective dose as a cornerstone therapy to repair the glucose sensor function of glucokinase, and when necessary, in combination with widely prescribed diabetes medicines such as metformin, DPP-4, SGLT2, GLP-1 or insulin through a personalized type 2 diabetes care approach. Our Phase III trial HMM302 [NCT03141073] targets patients who have failed metformin treatment and has recently completed enrollment. We are launching several clinical studies in the United States and China to investigate the effectiveness of dorzagliatin in different type 2 diabetes patient populations, and new indications in metabolic diseases and cognition.”

“This milestone is extremely important for the Chinese pharmaceutical market and the global diabetes community,” said Dr. Yang Wenying, leading principal investigator of HMM0302, former Director of Endocrinology and the Department of Internal Medicine, Metabolic Disease Research Center at China-Japan Friendship Hospital in Beijing, and former President of the Chinese Diabetes Society. “In addition to this important Phase III trial, we are also evaluating dorzagliatin’s efficacy in combination with other therapies in several additional ongoing clinical studies in China. We believe dorzagliatin offers new hope for addressing the underlying cause of type 2 diabetes.”

“We founded Hua Medicine approximately eight years ago to create a truly innovative biotechnology company based in China with the potential to benefit people living with diabetes worldwide,” said Mr. Robert Nelsen, Chairman of Hua Medicine and Managing Director and Co-Founder of ARCH Venture Partners. “With these 24-week top-line results from HMM0301, Hua Medicine becomes the first China-based biotech company to advance a global first-in-class drug candidate with a well-defined mechanism of action by achieving its primary efficacy endpoint, while also demonstrating a desirable safety profile. This is a significant milestone for the Hua Medicine team, Chinese investigators, and more importantly, for the global community of people impacted by diabetes.”

HMM0301 study design:

HMM0301 [NCT03173391] is a randomized, double-blind, placebo-controlled Phase III study in 463 drug naïve type 2 diabetes patients. Patients are treated with twice-daily doses of dorzagliatin (75 mg) or placebo, randomized 2:1. The clinical study evaluates the efficacy and safety of dorzagliatin during 24 weeks of double-blinded treatment, followed by a subsequent 28-week open-label treatment period, for a total of 52 weeks. The trial was conducted in compliance with the guidelines of the Chinese Society of Endocrinology, which require physicians to educate patients and strictly enforce improved exercise and dietary control, as well as continuous self-monitoring, in treating type 2 diabetes. The primary efficacy endpoint is evaluated at the conclusion of the first 24 weeks. The trial is being conducted at 40 clinical sites across China led by Professor Dalong Zhu, President of the Chinese Diabetes Society. Hua Medicine expects to release 52-week data in the second quarter of 2020.

Hua Medicine cannot guarantee that it will release its 52 week data in the second quarter of 2020 or it will be able to develop or ultimately market, dorzagliatin successfully.  Shareholders and potential investors of Hua Medicine are advised to exercise due care when dealing the shares of Hua Medicine.

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About Dorzagliatin

Dorzagliatin is a first-in-class, dual-acting glucokinase activator, designed to control the progressive degenerative nature of diabetes by restoring glucose homeostasis in people 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 people 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 in two Phase I trials in the United States. The company has also initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine's strategy is to leverage the cost-efficient and high-quality drug development capabilities available in China, while working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.

1 Defined as less than 3.0 mmol/liter per the American Diabetes Association – Standards of Medical Care in Diabetes – 2019.

2 Defined as hypoglycemia associated with severe cognitive impairment requiring external assistance for recovery without regard to any specific glucose threshold,  per the American Diabetes Association -- Standards of Medical Care in Diabetes - 2019  

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