English | 简体中文 | 繁體中文 | 한국어 | 日本語
Monday, 27 April 2020, 09:50 HKT/SGT
Share:
Hua Medicine Announces Positive Results in the Combination Study of Dorzagliatin with Empagliflozin (a SGLT-2 inhibitor)

SHANGHAI, Apr 27, 2020 - (ACN Newswire) - Hua Medicine (the "Company", Stock Code: 2552. HK) today announces the positive results of the clinical study HMM0112.

HMM0112 is a Phase I trial conducted in the United States in Type 2 Diabetes (T2D) patients with insufficiently controlled blood glucose levels while on metformin, DPP-4 inhibitors or SGLT-2 inhibitors, alone or in combination treatment. The principal purpose of HMM0112 is to investigate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of dorzagliatin and empagliflozin (a SGLT-2 inhibitor) as either monotherapy or combination therapy. The PK results demonstrated no impact of dorzagliatin (75 mg BID) and empagliflozin (25 mg QD) on their respective PK properties under co-administration, supporting their combination use in the clinical setting, while the PD results demonstrated a clear synergistic effect in efficacy under combination therapy. Following OGTT, the combination treatment achieved significantly enhanced glucose lowering effect (AUEC: 279 h.mg/dL) over empagliflozin (AUEC: 452 h.mg/dL, P<0.01) or dorzagliatin (AUEC: 364 h.mg/dL, P<0.05) monotherapy. Moreover, significantly increased C-peptide secretion was also observed for the combination treatment over empagliflozin monotherapy. These results support the development of a combination therapy of dorzagliatin with empagliflozin, which will provide improved benefits and better solutions to T2D patients.

"SGLT-2 inhibitors are a relatively newer class of oral medications for the treatment of T2D patients, in addition to the blood sugar control, they were found to have the effect to lower blood pressure and reduce body weight. Their global sales in 2019 were approximately 6 billion US dollars," said Dr. Li Chen, Chief Executive Officer of Hua Medicine, "The positive results of HMM0112 indicate that dorzagliatin add-on to SGLT-2 inhibitors enhanced the blood sugar control for T2D patients thereby expanding the applicable patient population, and also suggest a synergistic effect of recovering pancreatic islet function. This successful outcome advances our mission to offer dorzagliatin as either monotherapy or in combination with the currently approved top-selling oral anti-diabetic drugs. Currently, we have demonstrated similar positive results of dorzagliatin in combination with sitagliptin (a DPP-4 inhibitor and top-selling oral anti-diabetic drug in the world) and metformin (the global first-line oral anti-diabetic drug). In this fashion, we are aiming to provide a brand new treatment for T2D patients to prevent or delay occurrence of the diabetes and its complications through dorzagliatin monotherapy or in combination with currently available diabetes therapies."

In November 2019, Hua Medicine announced that the Phase III monotherapy trial (HMM0301) of dorzagliatin in drug naive T2D patients achieved its 24-week primary efficacy endpoint. The Company plans to announce the top-line 52-week key results for the monotherapy trial by no later than the third quarter of 2020. The 24-week patient visit for HMM0302, another Phase III combination trial of dorzagliatin add-on to metformin, was also completed. The Company plans to announce the top-line 24-week key results for the combination with metformin trial (HMM0302) by no later than the third quarter of 2020, and top-line 52-week key results by year-end 2020. In January 2020, the Company also announced the desirable results of dorzagliatin combination with sitagliptin Phase I trial (HMM0111), confirming the clinical advantages and potential synergies of dorzagliatin in combination with sitagliptin (a DPP-4 inhibitor). Meanwhile, the positive results of another Phase I trial (HMM0110) revealed the potential to use dorzagliatin in T2D patients with late stage chronic kidney disease.

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 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.

For more information

Hua Medicine
Website: www.huamedicine.com

Investors
Email: [email protected]

Media
Email: [email protected]



Topic: Press release summary
Sectors: Daily Finance, Daily News, BioTech, HealthCare
http://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2020 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.

 

Latest Press Releases
Five Advisors With Focus Partner Firm Escala Partners Named to Australia's Top 100 Financial Advisers 2020 List  
July 3, 2020 11:00 HKT/SGT
NEC and JAMSTEC Develop AI-based System for Measuring Microplastics in the Ocean  
July 3, 2020 10:30 HKT/SGT
Gynesys Best Home Security Urges Businesses to Work with African-American Owned Commercial Security Firms in the Aftermath of CPI Security CEO's Remarks; Prepared to Work with Carolina Panthers, Charlotte Hornets to Replace CPI as Major Sponsor  
July 2, 2020 15:00 HKT/SGT
Singapore's Leading B2B Tech Event Stack Rescheduled to 2021  
July 2, 2020 10:52 HKT/SGT
MOG Recorded a YOY Earnings Growth for the year ended 31 March 2020 by leveraging its extensive retail network and strong brand recognition to capture new market opportunities  
July 2, 2020 08:25 HKT/SGT
Hua Medicine Announces Positive 24-Week Topline Results of Phase III Metformin Combination Trial of Dorzagliatin  
July 1, 2020 19:00 HKT/SGT
Black Wealth Matters Welcomes SEC Internal Investigation Into Racist Attack on Solomon Ali; Demands Transparency and Accountability  
July 1, 2020 15:00 HKT/SGT
Fujitsu Revamps Corporate Philosophy 'FUJITSU Way' to Achieve Our Purpose  
July 1, 2020 13:22 HKT/SGT
Remap-Cap to Partner With Eisai on Innovative Trial to Combat COVID  
July 1, 2020 13:02 HKT/SGT
Toyota Launches New Acceleration Suppression System  
July 1, 2020 12:48 HKT/SGT
More Press release >>
 Events:
More events >>
Copyright © 2020 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Cookies Policy | Privacy Policy | Disclaimer | Terms of Use | RSS
US: +1 800 291 0906 | Beijing: +86 400 879 3881 | Hong Kong: +852 8192 4922 | Singapore: +65 6653 1210 | Tokyo: +81 3 6859 8575