Hua Medicine completes Phase I trial for innovative diabetes treatment
- Hua Medicine successfully completed a Phase I clinical trial on its 2nd generation GKA candidate known as HM-002-1005 in the U.S.
- The trial involved 40 subjects with Type 2 diabetes and was randomized, double-blind, placebo-controlled.
- The company plans to optimize the dosage form and continue clinical development in China and the U.S. following these promising results.
In Shanghai on November 30, 2024, Hua Medicine announced a significant achievement in clinical research with the successful completion of a Phase I trial for its new generation glucose-dependent insulinotropic polypeptide (GKA) candidate, HM-002-1005. Conducted in the United States, this study involved 40 subjects diagnosed with Type 2 diabetes (T2D). The trial was designed as a randomized, double-blind, placebo-controlled experiment focusing on safety, tolerability, and pharmacokinetics. The promising results suggest that the drug effectively maintains plasma concentrations and demonstrates favorable conversion rates in the human body. The trial aimed to enhance the oral administration of the treatment, leveraging innovative sustained-release technology, which allows for once-daily dosing. Dr. Li Chen, the founder and CEO of Hua Medicine, emphasized the company's commitment to addressing the root causes of Type 2 diabetes by enabling patients to better regulate their blood glucose levels autonomously. The research highlighted that the innovative tablets (HM-002-1005) yielded similar exposure levels in plasma compared with the previously established dorzagliatin tablets, suggesting potential for improved patient compliance due to the novel dosage form. The implications of this breakthrough extend to a broader patient base suffering from Type 2 diabetes, particularly among those who also face challenges associated with obesity. The design of the clinical trial considered varying disease characteristics and aimed to provide a more effective solution for patients in Western populations. Such advancements in Type 2 diabetes treatment are critical as the global prevalence of the disease continues to rise, necessitating innovative solutions to improve outcomes and patient satisfaction. Future steps for Hua Medicine involve optimizing the dosage forms and initiating Multiple Ascending Dose (MAD) clinical studies in both China and the United States. The company has established a clear path forward following this trial, aiming to leverage the findings to further develop the GKA candidate. With the current data showcasing promising pharmacokinetic properties, there is optimism within the company regarding the future of HM-002-1005 as a leading treatment for Type 2 diabetes.