Continuing its momentum after raising $25 million in Series B financing earlier this year, Hua Medicine, an innovative biotechnology company in Shanghai, has announced the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for its novel 4th-Generation glucokinase activator (GKA) to treat Type 2 diabetes (T2DM). The company had earlier announced outstanding positive results from a multicenter Phase 1b trial in China. HMS5552 (also known as sinogliatin) demonstrated excellent 24-hour glucose control of both fasting and post-meal glucose, robust glucose-dependent insulin release, and very low risk of hypoglycemia throughout the trial in Chinese T2DM patients. The company will start long-term Phase 2 trials in China in the 2Q2015, while concurrently starting the Phase 1 metformin-GKA combination studies in the US.
"HMS5552 continues to show outstanding glucose control in diabetic patients while maintaining its excellent safety profile. The Phase 1b results already suggest that GKA will be very effective as a monotherapy in Chinese T2DM patients. Expanding its development in the US, we are investigating sinogliatin's potential to work synergistically in combination with metformin (the current first-line, oral therapy for T2DM in the US). Overall, this fits our strategy to broadly develop sinogliatin for the benefit of patients worldwide," stated Dr. Li Chen, CEO of Hua Medicine.
The US Phase 1 trial will study drug-drug interactions of sinogliatin in combination with metformin in American T2DM patients and will finish by YE 2015. The company is also initiating a multicenter Phase 2 trial in Chinese diabetic patients that is expected to complete enrollment by YE 2015, with topline results available by 2Q2016. This will be a 12-week, randomized, double-blind, placebo-controlled trial in approximately 280 diabetic adult male and female patients. In addition to evaluating sinogliatin's safety and efficacy (as determined by HbA1c lowering at the end of 12-weeks), the China trial will continue to evaluate potential improvements in beta-cell health. These results in multiple ethnic populations are expected to further support sinogliatin's novel mechanism of action and give guidance for trial design and optimal patient selection in future Phase 3 trials.
About Hua Medicine
Hua is a leading, innovative drug development company in China focused on novel therapies for the treatment of diabetes and CNS disorders. Founded by an experienced group of entrepreneurs and international investment firms, Hua currently has world-wide rights to two novel assets. The most advanced program is a first-in-class, oral drug for the treatment of Type 2 Diabetes that will shortly initiate Phase 2 trials in China. The company has also internally developed earlier-stage compounds focused on a highly validated CNS target for multiple indications including Parkinson's Disease associated dyskinesia and Depressive Disorder. Hua's strategy is to leverage the cost-efficient and high-quality drug discovery capabilities available in China, while partnering or licensing the most promising drug assets from the US and abroad. Through these efforts, Hua intends to be the driving force behind China's evolution into a global innovation center for drug development. For more information: www.huamedicine.com