June 7, 2022, Shanghai, China
Hua Medicine (the "Company", stock code: 2552.HK) today announces that several clinical findings were presented on its global first-in-class drug, glucokinase activator (GKA) dorzagliatin, at the 82nd American Diabetes Association (ADA) Annual Scientific Sessions. A post-hoc analysis that involved two Phase III clinical trials of dorzagliatin indicated that dorzagliatin can significantly improve early phase insulin secretion and glucose sensitivity of patients of Type 2 diabetes (T2D).
Professor Wenying Yang of the China-Japan Friendship Hospital, and former Chairman of the Chinese Diabetes Society and currently serving as Vice President of the Asian Association for Study of Diabetes and Hua Medicine’s medical team, conducted a multivariate logistic regression analysis of the two Phase III clinical trials of dorzagliatin monotherapy (SEED), for which she participated in, and metformin add-on (DAWN), for which she served as lead principal investigator. The analysis found significant correlation between subjects who reached blood glucose control rate after treatment and the improvement in select key measures of β-cell secretion function, such as early phase insulin secretion index and disposition index. The study further indicated that as a global first-in-class GKA drug, dorzagliatin can restore the deteriorated glucose sensing function of glucokinase (GK) in T2D patients, systematically improve islet β-cell function, improve early phase insulin secretion and glucose sensitivity, and thereby restore the ability of T2D patients to regulate blood glucose autonomously and promote glycosylated hemoglobin levels in T2D patients (HbA1c< 7%).
Conducted by Professor Jianhua Ma, Director of the Department of Endocrinology, Nanjing First Hospital, Standing Member of the Chinese Diabetes Society, the results of the DREAM study were also presented at ADA 2022. It is the first time that the result on diabetes remission of dorzagliatin was presented at an international academic conference, attracting widespread attention from the participants. The DREAM study is a non-drug intervention observational clinical study initiated by certain researchers participating in the SEED study. The main purpose of this study is to evaluate the remission of diabetes for 52 weeks after patients who completed the SEED study and whose blood glucose reached control targets, and stopped taking dorzagliatin as well as any other glucose-lowering medication. The results of the study showed that during the observation period when no anti-diabetes drugs were administered, the remission rate was 65.2% at 52 weeks. HbA1c, FPG and 2h-PPG levels were sustained during the 52 weeks after dorzagliatin discontinuation and β-cell function remained stable. The study indicated that dorzagliatin has a promising treatment option for achieving remission of diabetes in newly diagnosed unmediated patients by rapidly restoring early phase insulin secretion and lasting improvement of β-cell function.
Another clinical study called SENSITIZE also provided clinical scientific data of dorzagliatin in improving insulin secretion and glucose sensitivity. The study, initiated by Professor Juliana Chan, an international recoginzed endocrinologist from the Chinese University of Hong Kong, explored the effects of dorzagliatin on patients with recent onset T2D and glucokinase-maturity-onset diabetes of the young (GCK-MODY or MODY-2). The study results of SENSITIZE were presented to the public for the first time at the ADA Annual Scientific Sessions. The study results, using glucose clamp technique, showed that dorzagliatin can significantly improve second phase insulin secretion and glucose sensitivity in GCK-MODY patients and can significantly improve basal insulin secretion rates in patients with recent onset T2D. As the speaker of the oral presentation and one of the researchers of the SENSITIZE study, Professor Elaine Chow from the Chinese University of Hong Kong, won the 2022 Women's Interprofessional Network of the American Diabetes Association (WIN ADA) abstract award in the category of Clinical Diabetes, Epidemiology, and Diabetes Complications in recognition of her outstanding results and significant contributions in the SENSITIZE study and the whole field of diabetes research. The potential application of dorzagliatin in this special rare disease population of GCK-MODY, has attracted the attention of the international diabetes research field.
The WIN ADA abstract award category of Clinical Diabetes, Epidemiology, and Diabetes Complications is an important part of WIN ADA awards, voted by WIN ADA Advisory Group, consisting of expert clinicians, scientists, educators, public health practitioners, and other diabetes professionals. The awards are established to recognize outstanding women who have made significant contributions to diabetes research, clinical care, public health, education, and related areas.
Dr. Li Chen, Founder, CEO and Chief Scientific Officer of Hua Medicine, said, “In 2012, Hua Medicine proposed the development of GKA based on the concept of glucose homeostasis, the core of which is to treat diabetes from the root cause of T2D, addressing the issues of glucose sensitivity and insulin resistance. Concept innovation is the main focus of new drug innovation research, and Hua Medicine has spent ten years to select a safe and effective dosing regimen and clinical study proposal suitable for most diabetic patients in China, thereby contributing to the successful development of GKA. The clinical findings presented at the ADA 2022 further demonstrate the scientific concept of dorzagliatin to ‘repair the sensor, restore homeostasis, and treat the underlying cause of diabetes’. The findings also provide a scientific basis for studies on dorzagliatin monotherapy and as a cornerstone drug in combination with other OADs for the treatment of T2D, as well as for achieving remission and regression of diabetes in patients with recent onset of T2D, and boost our confidence to further personalize diabetes treatment and to cure diabetes.”
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive and degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By fixing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired insulin and GLP-1 secretion of patients with Type 2 diabetes and serve as a cornerstone therapy targeting the root cause of the disease. Two Phase III registered trials for dorzagliatin monotherapy and the combination of dorzagliatin and metformin respectively have been completed in China, as well as the studies on drug mechanism synergy with sitagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2 inhibitor). In an investigator-initiated study named as DREAM, a 65.2% diabetes remission rate was observed when they stopped dorzagliatin and no other antidiabetes medication was taken during the 52-week study period. The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Medical Products Administration, and has submitted its NDA to the National Medical Products Administration in order to realize the "First in Global, Start from China" mission for the benefits of diabetic patients worldwide.
About Hua Medicine
Hua Medicine is an innovative drug development company in China focused on developing novel therapies for patients worldwide with unmet medical needs. Hua Medicine teams up with global high caliber people and integrates global resources to explore breakthrough technologies and products and accelerate global innovation in diabetes care. Targeting the glucose sensor glucokinase, dorzagliatin, a novel oral diabetes drug restoring glucose sensitivity in T2D patients, has completed SEED and DAWN registration trials, and filed NDA in China. This global first-in-class glucokinase activator (GKA) has demonstrated its potential of achieving diabetes remission to help millions of diabetic patients around the world.
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