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Hua Medicine to Release Phase III 24-Weeks Topline Data of Dorzagliatin Monotherapy Trial (HMM0301) on November 12SHANGHAI, China, Nov. 08, 2019 (GLOBE NEWSWIRE) -- Hua Medicine (HKEX: 2552), a Shanghai-based drug development company focused on developing a global first-in-class oral drug for the treatment of type 2 diabetes, today announced that 24-week topline data of dorzagliatin’s monotherapy trial (HMM0301) will be released on November 12, 2019, and management will present the results and answer any questions via conference call. Date: November 12, 2019 (Tuesday) Dial in details:
HMM0301 [NCT03173391] is a Phase III registration trial targeting Chinese drug naïve patients, positioning dorzagliatin as first-line therapy. The monotherapy trial is a double-blind, placebo-controlled study, and patients are randomized 2:1 to receive either dorzagliatin or placebo. 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, for a total of 52 weeks. The primary efficacy endpoint is evaluated at the conclusion of the first 24 weeks. Enrollment for the trial was completed on February 28, 2019. The trial is being conducted in over 40 clinical centers across China, led by Dr. Dalong Zhu, President of the Chinese Diabetes Society. About Dorzagliatin (HMS5552) 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 type 2 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. For more information: [email protected] www.huamedicine.com
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