FDA Puts Brake On vTv Therapeutics' Diabetes Candidate Program, Including Late-Stage Study, Stock Tanks

vTv Therapeutics Inc. VTVT stock is trading lower on Monday. The FDA has placed a clinical hold on the cadisegliatin clinical program, which includes the ongoing CATT1 Phase 3 trial in type 1 diabetes. 

Cadisegliatin is an oral, liver-selective, glucokinase activator. The company says the drug candidate has been well-tolerated in over 500 subjects to date with up to six months of treatment.

Related: Why Is Diabetes Focused vTv Therapeutics Stock Trading Higher Today?

Selectively acting on the liver, cadisegliatin increases the activity of glucokinase independently from insulin to improve glycemic control through hepatic glucose uptake and glycogen storage.

The clinical hold was based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy.

The agency requires a single in vitro study to characterize this signal before the cadisegliatin program can resume.

No patient had been dosed in CATT1 at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues.

“We are working diligently with the agency to resolve the clinical hold and resume enrollment as quickly as possible,” said Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics.

Price Action: VTVT stock is down 32.2% at $14.38 at the last check on Monday.

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