Hua Medicine announced the successful completion of the Phase I clinical study of the second-generation glucokinase activator conducted in the United States.
Source: Hua Medicine
Hua Medicine announced the successful completion of the Phase I clinical study of the second-generation glucokinase activator conducted in the United States
Shanghai, November 30, 2024 - (Asia Pacific Business Wire) - Hua Medicine ("the Company", HKEX stock code:$HUA MEDICINE-B(2552.HK)) today announced at the 9th China BioMed Innovation and Investment Conference (CBIIC) the successful completion of the Phase Ia clinical study of its second-generation glucokinase activator (GKA) conducted in the United States.
The Phase Ia clinical trial of the second-generation GKA (HM-002-1005) was a randomized, double-blind, placebo-controlled, single-dose study evaluating safety, tolerability, and pharmacokinetics in 40 subjects with type 2 diabetes (T2D) in the U.S. The second-generation GKA is a new molecular entity with optimized physicochemical properties and novel patents, serving as a prodrug of dorzagliatin (HMS5552). The study design featured once-daily oral administration, aiming to prolong drug action through sustained-release technology, improve patient compliance, and extend the stimulation of GLP-1 secretion in the intestines.
Results from this single ascending dose (SAD) study showed that HM-002-1005 tablets rapidly converted to HMS5552 in humans, with minimal prodrug exposure in plasma and urine. The t1/2 (biological half-life) of HM-002-1005 after single dosing was prolonged compared to dorzagliatin tablets. After a single 184.5mg dose, the Cmax of HMS5552 in plasma was comparable to that after a single 75mg dose of dorzagliatin tablets; meanwhile, the daily AUC of HMS5552 in plasma matched the exposure level of HMS5552 after twice-daily 75mg dorzagliatin dosing. The study demonstrated near-complete conversion of HM-002-1005 to HMS5552 in humans, with pharmacokinetic profiles supporting once-daily oral administration. The development of HM-002-1005 tablets not only enhances patient compliance but also enables effective 24-hour blood glucose control while providing opportunities to explore maximum tolerated doses above 150mg/day for better therapeutic outcomes. The twice-daily (BID) 75mg dorzagliatin regimen was developed based on the minimal effective therapeutic dose concept, targeting insulin secretion defects and significantly reduced early-phase insulin secretion commonly seen in Chinese T2D patients. Western T2D patients exhibit different disease characteristics, often with obesity comorbidities. Dorzagliatin’s ability to promote GLP-1 secretion and improve insulin sensitivity may offer new benefits for this patient population.
The study confirmed that exposure levels from a 184.5mg HM-002-1005 tablet are comparable to 75mg BID dorzagliatin tablets. The Company will further optimize the formulation and proceed with multiple ascending dose (MAD) clinical development of the second-generation GKA in China and the U.S.
Dr. Li Chen, Founder and CEO of Hua Medicine, stated: "Hua Medicine remains committed to treating type 2 diabetes at its root by restoring patients' glucose self-regulation capabilities. Over a decade, we’ve identified safe and effective dosing regimens and clinical protocols for most Chinese diabetes patients, achieving successful GKA development and dorzagliatin’s clinical application. Building on this, we will strategically upgrade by exploring GKA’s therapeutic potential, enriching our pipeline, seeking global partnerships to benefit more patients, expanding internationally, and realizing the commercial value of first-in-class GKA drugs."
About Hua Medicine
Hua Medicine ("the Company") is an innovative drug R&D and commercialization company headquartered in Shanghai, China, with subsidiaries in the U.S. and Hong Kong. Focused on unmet medical needs, Hua Medicine develops novel therapies for global patients. By assembling top-tier talent, integrating global innovations, and leveraging worldwide resources, the Company pioneers breakthrough technologies and products in diabetes care. Its core product HuaTangNing (R) (dorzagliatin tablets) targets glucose sensor glucokinase to enhance glucose sensitivity and restore glycemic homeostasis in T2D patients. On September 30, 2022, HuaTangNing (R) received marketing approval from China’s NMPA for monotherapy or combination with metformin in adult T2D treatment. With no dose adjustment required for renal impairment, it is the first oral antidiabetic drug suitable for T2D patients with kidney damage.$HUA MEDICINE-B(02552.HK)
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