Hua Medicine of Shanghai has filed an Investigational New Drug (IND) application with the FDA to begin US clinical trials of its novel type 2 diabetes treatment, a 4th-generation glucokinase activator (GKA). In February, Hua filed to start a Phase II trial of sinogliatin in China, after reporting positive Phase Ib data. Hua in-licensed global rights to sinogliatin from Roche (SIX: ROG) in 2011.

In the China Phase Ib trial, sinogliatin was both safe and effective, controlling both fasting and post-meal blood glucose levels with only a low risk of hypoglycemia. Usually, Hua explains, this requires two drugs.

The China trial administered the drug as a monotherapy. In the US trial, sinogliatin will be given together with metformin, which is currently the first-line oral therapy for type 2 diabetes treatment in the US.

The US Phase I trial will study the drug-drug interactions of sinogliatin and metformin in American type 2 diabetes patients. It will be completed by year-end 2015. Hua plans to complete enrollment of the multicenter Phase II trial in Chinese diabetic patients by year-end 2015, with topline results available in the Q2 of 2016. The China trial 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 evaluate potential improvements in beta-cell health. Hua expects the results from different ethnic populations to provide proof-of-concept for sinogliatin’s novel mechanism of action and help design the trial and patient selection criteria for Phase III trials.

In January, Hua closed a $25 million Series B financing that will underwrite the China Phase II clinical trial of sinogliatin and the Phase I trial in the US (see story). Hua, which raised $50 million in its initial funding, was co-founded by Dr. Ge Li, the CEO of WuXi PharmaTech (NYSE: WX) and WuXi participated in the first funding round.

“HMS5552 continues to show outstanding glucose control in diabetic patients while maintaining its excellent safety profile," said Dr. Li Chen, CEO of Hua Medicine in a statement. "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. Overall, this fits our strategy to broadly develop sinogliatin for the benefit of patients worldwide.”

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Disclosure: none.