Pivotal Phase III Trial Achieved Clinical Efficacy Endpoint at 24 Weeks
Dorzagliatin-Driven Portfolio Expands
Hua Medicine (the “Company”, Stock Code on The Stock Exchange of Hong Kong Limited: 2552.HK), a global innovative drug research and development company focused on novel therapies for the treatment of diabetes, today announces the audited consolidated results of the Company and its subsidiaries for the year ended December 31, 2019. For the year ended December 31, 2019, the Company incurred approximately RMB468.5 million in total expenses, of which approximately RMB 321.9 million was research and development expenses. As of December 31, 2019, the Company’s cash position was approximately RMB 1,105.6 million.
Hua Medicine will continue to execute on its strategic goal of becoming a global diabetes care and management company, and is devoted to the development, registration and launch of dorzagliatin (HMS5552) in China and around the world. Hua Medicine achieved many milestones in 2019. The core scientific concept for dorzagliatin as a first-in-class drug was further validated, and the dorzagliatin-driven portfolio of diabetes therapies reflected in our pipeline continued to expand and advance. The Phase III monotherapy trial (HMM0301) for dorzagliatin (HMS5552) achieved its primary efficacy endpoint. The study results indicated that dorzagliatin was well tolerated during the 24-week study period, exhibited very low incidences of hypoglycemia and had a good safety profile. Meanwhile, two Phase I clinical trials with dorzagliatin (HMM0110 and HMM0111) also demonstrated satisfactory results. The results of HMM0110 demonstrated that dorzagliatin has the potential to be used in Type 2 diabetes (T2D) patients with moderate, severe and end stage chronic kidney disease (i.e., stages 3-5 of CKD); several top-selling oral anti-diabetes drugs must undergo dose adjustment (e.g., metformin and sitagliptin) when used for such T2D patients, or simply can’t be used at all for such patients (e.g., select SGLT-2 inhibitors). The results of HMM0111 confirmed the clinical advantages and potential synergies of dorzagliatin in combination with sitagliptin (a DPP-4 inhibitor), one of the best-selling oral anti-diabetic drugs globally.
The diagnosis rate of Type 2 diabetes is relatively low in China. Accordingly, there is a huge population of non-diagnosed and drug-naive T2D patients in China, which provides a big market opportunity for dorzagliatin. Current diabetes therapies still cannot effectively restore the healthy body’s ability to control blood glucose level autonomously, nor modify or stop the progression of diabetes into more advanced stages of the disease, leading to the development of diabetes-associated complications. In contrast, the results of pre-clinical and clinical studies (both completed and those currently under development) demonstrate that dorzagliatin has the potential to treat the underlying cause of Type 2 diabetes by fixing the impaired glucose sensor in all T2D patients and thereby restoring glucose homeostasis. Research data to date suggests that, as a cornerstone therapy, dorzagliatin possesses the potential of controlling the development of diabetes and preventing or delaying the occurrence of complications, either via monotherapy or through combination with currently available diabetes therapies.
“We will carry on implementing our developmental strategy, which consists of expanding in three dimensions: new products, global markets and new disease indications. By deploying dorzagliatin as a cornerstone therapy, we will establish an innovative, sharing and win-win scientific platform that focuses on the remodeling of glucose homeostasis, and eventually realize the personalized medicine of diabetes globally,” said Dr. Li Chen, Founder and Chief Executive Officer of Hua Medicine.
Clinical trial Highlights
– Achieved 24-week primary efficacy endpoint in a double blinded placebo controlled Phase III trial in drug naive Type 2 diabetes (T2D) patients in China (HMM0301), with very low hypoglycemia incidents and good safety profiles. As of March 2, 2020, the last patient out, 52-week (plus one-week follow-up) patient visit for HMM0301 was completed.
– Completed enrollment in a metformin add-on Phase III registration trial (HMM0302). As of February 16, 2020, the 24-week patient visit for HMM0302 was completed.
– Completed HMM0110, which demonstrated desirable pharmacokinetics profile in patients with end stage chronic kidney disease, indicating the potential use of dorzagliatin among T2D patients with moderate, severe and end stage chronic kidney disease (i.e. stages 3-5 of CKD).
– Completed HMM0111, which investigated the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of dorzagliatin either alone or in combination with sitagliptin (a DPP-4 inhibitor) in T2D patients, and demonstrated combination and synergy potential between the two drugs.
– Granted a formulation patent for dorzagliatin in China.
– Filed six patent applications covering the IPR of fixed dose combination of dorzagliatin with six classes of oral anti-diabetic drugs.
– Fully validated the cGMP (current Good Manufacturing Practice) commercial manufacturing processes for active pharmaceutical ingredient (API) and drug product to support the launch of dorzagliatin in China.
Operational highlights
– Initiated a formal collaboration relating to the central role of glucokinase in controlling glucose homeostasis with Dr. Franz Matschinsky,professor of Biochemistry and Biophysics, Institute for Diabetes, Obesity and Metabolism Perelman School of Medicine, Philadelphia and the recipient of the 1995 Banting Medal for Scientific Achievement and the 2020 Rolf Luft Award.
– Presented AI-based machine learning results at the American Diabetes Association’s 79th Scientific Sessions, providing a non-biased methodology to sub-classify T2D patients.
– Announced that global operation headquarters and research and development center were established in Shanghai’s ZhangJiang Science City.
– Former U.S. FDA Officer Dr. Fuxing Tang joined Hua Medicine as Chief Technology Officer, VP of Formulation R&D and Product Development.
Financial Highlights
– Cash position was approximately RMB1,105.6 million as of December 31, 2019.
– Loss before tax decreased by approximately RMB3,178.7 million or approximately 88.2% to approximately RMB425.3 million.
Future Pipeline Outlook
– The Company plans to announce top-line 52-week Phase III trial result for the monotherapy trial (HMM0301) by no later than third quarter 2020.
– The Company plans to announce top-line 24-week Phase III result for the combination with metformin trial (HMM0302) by no later than third quarter 2020, and top-line 52-week result by year end 2020.
– The Company plans to partner with either China-based or international pharmaceutical companies to make dorzagliatin and related products, as brand new therapies, available to patients, in both China and regions outside of China.
– HMM0109 is a Phase I trial studying the pharmacokinetics profile for hepatic impaired patients in China.
– HMM0112 is a dorzagliatin combination with empagliflozin (a SGLT-2 inhibitor) Phase I trial in T2D patients in the United States. The Company announced the first patient was dosed in April 2019 and expect to complete and announce results by first half 2020.
– In order to continue expansion of dorzagliatin’s indications for the treatment of T2D, the Company is investigating the combination of dorzagliatin with various approved classes of oral anti-diabetic medicines and expand the dorzagliatin-driven portfolio to address patients’ personal needs.
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 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.