Hua Medicine (the Company, HKG: 2552) announced today that the Company has successfully completed a Phase I clinical trial on its 2nd generation GKA candidate in U.S. at the 9th China BioMed Innovation and Investment Conference (CBIIC).
The Phase Ia clinical trial of the second-generation GKA (HM-002-1005) was conducted in the United States in 40 subjects with Type 2 diabetes (T2D). This trial was randomized, double-blind, placebo-controlled, single-dose, focusing on safety, tolerability, and pharmacokinetics. The second-generation GKA is a novel molecular entity with optimized physicochemical properties, holding new patents, and serving as the prodrug of dorzagliatin (HMS5552). This study designed for once-daily oral administration. Its aim is to extend the drug’s action duration in the body through sustained-release technology, enhance patient compliance, and prolong the stimulation of GLP-1 secretion in the intestines.
The Single Ascending Dose (SAD) study demonstrates that HM-002-1005 tablets can be rapidly converted to HMS5552 in the human body, with minimal exposure level of prodrug in both blood and urine. The t1/2 (biological half-life) after a single dose of HM-002-1005 tablets was prolonged compared to dorzagliatin tablets. The Cmax of HMS5552 in plasma after a 184.5mg single dose is comparable to the plasma concentration of HMS5552 after a 75mg single dose of dorzagliatin tablet; likewise, the daily AUC of HMS5552 in plasma after a single dose of HM-002-1005 tablets is comparable to the exposure level of HMS5552 after a 75mg BID dose of dorzagliatin tablets. The research indicates that HM-002-1005 tablets are near-completely converted to HMS5552 in human, and its pharmacokinetic characteristics support for once-daily oral administration. The development of HM-002-1005 tablets not only contributes to enhancing patient medication adherence and effectively control blood glucose levels within 24 hours; meanwhile, it also offers the opportunity to explore the Maximum Tolerated Dose above 150mg daily to achieve better efficacy. The 75 mg BID dose regiment was developed under the concept of Minimum Therapeutic Effective Dose in Chinese T2D patients who suffered from an impairment of insulin secretion and significant reduction of early phase insulin. The different disease characters of T2D with obesity in western patient population would benefit dorzagliatin from its effects on GLP-1 secretion and improvement of insulin sensitivity.
With the confirmation that the exposure level of HM-002-1005 tablets at 184.5mg is comparable to dorzagliatin tablets at 75mg (BID), we will further optimize the dosage form followed by a Multiple Ascending Dose (MAD) clinical development of the 2nd generation GKA in China and the United States.
Dr. Li CHEN, founder and CEO of Hua Medicine, stated, “Hua Medicine has always been committed to treating Type 2 diabetes at its root cause by restoring patients’ ability to autonomously regulate blood glucose levels. Over the course of a decade, the Company has selected dosing and clinical research protocols that are safe and effective for the majority of Chinese diabetes patients, leading to the successful development of GKA and the clinical application of dorzagliatin. Building on this foundation, the Company will undergo a strategic upgrade by further exploring the therapeutic potential of GKA, enriching its product pipeline and seeking partners both domestically and internationally, in order to benefit a broader range of patients, expand into global markets, and effectively establish the brand identity of GKA medications while maximizing the commercial potential of our global first-in-class drugs.”
About Hua Medicine
Hua Medicine (The Company) is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine’s cornerstone product HuaTangNing (Dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin for adult T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with renal function impairment.
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