vTv Therapeutics Inc. (VTVT) announced on Friday that the United States Food and Drug Administration (FDA) has imposed a clinical hold on the cadisegliatin program, which includes the ongoing CATT1 Phase 3 trial for type 1 diabetes. Following this news, shares plummeted 36% in after-hours trading.
Cadisegliatin, an oral, liver-selective glucokinase activator, has been well-tolerated by over 500 participants during treatment periods of up to six months.
The clinical hold stems from the identification of a chromatographic signal in a recent ADME (absorption, distribution, metabolism, and excretion) study of cadisegliatin, which could not be resolved using standard mass spectroscopy. The FDA requires a specific in vitro study to further characterize this signal before the cadisegliatin program can proceed. It is noteworthy that no patients had commenced dosing in the CATT1 study at the time of the clinical hold, and previous clinical trials have not identified any critical safety concerns.
"Patient safety is our paramount concern, and we appreciate the FDA's thorough approach to better understand this signal. We are working diligently with the Agency to lift the clinical hold and expedite the resumption of patient enrollment," stated Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics. "Cadisegliatin has shown promising efficacy and a favorable safety profile in over 500 subjects so far. We are optimistic about its potential to significantly improve glycemic control and serve as a crucial oral therapy for type 1 diabetes."
Cadisegliatin (TTP399) is an innovative, oral, small molecule liver-selective glucokinase activator with first-in-class potential as an adjunct treatment for type 1 diabetes (T1D). By selectively targeting the liver, cadisegliatin enhances glucokinase activity independently of insulin, thereby improving glycemic control through increased hepatic glucose uptake and glycogen storage.
