Metabasis Launches Trial of Treatment for Type 2 Diabetes

Metabasis Therapeutics has initiated a Phase IIa clinical trial for MB07803, a product candidate being studied as a treatment for patients with Type 2 diabetes. MB07803 is the second member of a new class of drugs discovered by Metabasis that inhibit a metabolic pathway in the liver called gluconeogenesis, which is responsible for the excessive production of glucose by patients with Type 2 diabetes.

The proof-of-concept study will be a randomized, double-blind, placebo-controlled, 28-day trial involving approximately 60 patients with Type 2 diabetes. One group will receive a placebo, and the other four groups will receive different doses of MB07803 administered once daily. The study will evaluate the change from baseline in fasting plasma glucose levels of MB07803-treated patients relative to placebo-treated patients after 28 days of therapy.

Four Phase I clinical trials for MB07803 were completed during 2006. While the company is still evaluating the data from these studies, the product candidate was found to be safe and well tolerated. No serious adverse events were seen, all adverse events were mild and there were no withdrawals due to adverse events.

MB07803, along with the first candidate in this category, CS-917, is designed to regulate glucose production in the liver by inhibiting an enzyme known as fructose 1,6- bisphosphatase, a key component of the gluconeogenesis pathway.

CS-917 is being developed by Metabasis' partner, Daiichi Sankyo. Daiichi Sankyo has completed two successful Phase IIa studies and is currently conductiong a Phase IIb clinical trial.

"The clinical success achieved to date with CS-917 by our partner increases our confidence in the potential of MB07803," Mark Erion, executive vice president of R&D and chief scientific officer, said.