August 20, 2008 — Activx Biosciences, Inc., a wholly owned subsidiary of Tokyo-based Kyorin Pharmaceutical Co., Ltd., announced topline results from their Phase Ib and Phase IIa clinical trials with KRP-104, a dipeptidyl peptidase-4 (DPP-4) inhibitor, for the treatment of type 2 diabetes. In Phase IIa, KRP-104 was shown to be well tolerated and efficacious in the treatment of hyperglycemia in patients with type 2 diabetes resulting in highly significant improvements in glycemic control compared to placebo.The open labeled, cross-over, Phase Ib trial of KRP-104 in the US enrolled 28 patients with type 2 diabetes and showed equivalent efficacy on glucose-lowering to a competitive drug.
The randomized, double-blind, placebo-controlled, multi-center Phase IIa trial in the US and India enrolled 220 patients with type 2 diabetes inadequately controlled on metformin alone. The study evaluated the safety, tolerability, and efficacy of a total daily dose of 120 mg of KRP-104, administered either as a once daily (QD) dose or as a split dose of 60 mg (BID) added to stable metformin therapy for 12-weeks of treatment. Both dosing regimens provide greater than 95% inhibition of DPP-4 during daytime hours, but the BID dosing regimen provides this high level of inhibition continuously, whereas the QD dose results in considerably less DPP-4 inhibition overnight... Activx Biosciences' Press Release -
