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news.Metabasis Therapeutics has announced that MB07803 met its primary efficacy endpoint with results demonstrating a statistically and clinically significant reduction in fasting plasma glucose at day 28 in its Phase IIa clinical trial.
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This 28-day proof-of-concept clinical trial was a randomized, double-blind, placebo-controlled trial involving 105 patients with type 2 diabetes with a mean baseline fasting plasma glucose of 187mg/dL and mean baseline HbA1c of 8.2%. Patients received either placebo or MB07803 at an oral dose of 10, 50, 100 or 200mg once daily.
The primary efficacy endpoint of the trial was achieved with MB07803 administered at 200mg once a day resulting in a statistically and clinically significant reduction in FPG at day 28 versus placebo (p=0.0177). This clinical trial showed that MB07803 was safe and well tolerated with 94% of the patients completing the study and no patients withdrawing due to drug-related adverse events.
Howard Foyt, vice president of clinical development of Metabasis, said: “The results of this study provide, for the first time, evidence that MB07803 lowers fasting plasma glucose levels in patients with type 2 diabetes.”