vTv Therapeutics announced that the FDA has placed a clinical hold on its cadisegliatin program, including an ongoing phase 3 trial for type 1 diabetes.
The hold was made due to discovery of a chromatographic signal in a recent human ADME study of cadisegliatin that could not be resolved by standard mass spectroscopy. The FDA requires an in vitro study to characterize this signal before the program can resume. The hold includes the CATT1 phase 3 study, though no patients had been dosed in the trial at the time of the hold, and previous clinical studies did not reveal any safety concerns.
Cadisegliatin is an oral, liver-selective glucokinase activator that has been well-tolerated in over 500 subjects with up to six months of treatment. Cadisegliatin is designed to increase glucokinase activity in the liver independently of insulin, aiming to improve glycemic control through enhanced hepatic glucose uptake and glycogen storage.
The North Carolina-based biotech has focused on developing novel oral, small molecule drug candidates for chronic diseases. Cadisegliatin leads its clinical pipeline as a potential adjunctive therapy to insulin for type 1 diabetes.
