Amylin's AC2993 meets endpoints in Ph II trial

Amylin Pharmaceuticals presented positive results from a Phase II studyof its diabetes drug candidate, AC2993 (synthetic exendin-4) at the recent American Diabetes Association meeting, in which all three dosing regimens achieved statistically-significant reductions in hemoglobin A1c and fructosamine compared to placebo.

109 patients with type 2 diabetes who were inadequately controlled with sulfonylureas and/or metformin (HbA1c greater than or equal to 8) were enrolled in the trial. AC2993 treatment led to statistically-significant reductions in mean HbA1c (-1.1% to -0.7%) compared with placebo (-0.3%). Reductions in HbA1c of greater than or equal to 0.5% were achieved by 90% of AC2993 subjects compared with 33% of placebo subjects. The most common adverse event reported was mild-to-moderate nausea, consistent with previous AC2993 clinical studies.

The company noted that this level of HbA1c reduction represents a clinically-meaningful improvement in glucose control and puts the drug on track to enter Phase III development.