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vTv Therapeutics Inc., a clinical-stage biopharmaceutical company engaged in discovery and development of new orally administered treatments for Alzheimer’s disease and diabetes, announced positive topline results from a placebo and active-comparator-controlled Phase 2b clinical study of TTP399, a liver-selective glucokinase activator under development for the treatment of Type 2 diabetes.
Topline results showed achievement of the primary endpoint of statistically significant change from baseline in HbA1c at 6 months of daily administration of 800 mg of TTP399. The reduction in HbA1c was dose-dependent and sustained throughout the duration of the study. TTP399 was also found to be well-tolerated. Further analysis of the data is ongoing.
“We are extremely pleased with these findings from our Phase 2b study of TTP399,” commented Steve Holcombe, President and CEO of vTv Therapeutics. “These results show that a glucokinase activator with hepatic selectivity may lead to a meaningful reduction in HbA1c on a sustained basis. We are enthusiastic about advancing TTP399 to the next stage of development.”
“We now have a glucokinase activator that appears to improve glucose control in a safe and sustained manner. I believe the Phase 2 results suggest that TTP399 may become a significant treatment option in diabetes care,” said Dr. John Buse, Director of the North Carolina Translational and Clinical Sciences Institute and of the Diabetes Center at the University of North Carolina School of Medicine and a member of the vTv Therapeutics Scientific Advisory Board.
The Phase 2b AGATA (Add Glucokinase Activator to Target A1c) is a six-month, double-blind, placebo- and active-controlled parallel group trial in 190 patients with Type 2 diabetes on a stable dose of metformin. The primary endpoint was change from baseline in HbA1c at six months.
A manuscript with more details is in preparation and will be submitted for publication to a major medical journal.
