Hua Medicine Announces Successful U.S. Phase I Results on Its 2nd Generation GKA Candidate

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Saturday, 30 November 2024, 21:08 HKT/SGT Source: Hua Medicine Hua Medicine Announces Successful U.S. Phase I Results on Its 2nd Generation GKA Candidate

SHANGHAI, Nov 30, 2024 – (ACN Newswire) – Hua Medicine (the “Company”, HKEx stock code: 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 … Read More