FDA Halts vTv Therapeutics Diabetes Program

vTv Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has imposed a clinical hold on its cadisegliatin program. This decision affects the ongoing phase 3 trial focused on type 1 diabetes, known as the CATT1 study. The halt arose following the detection of a chromatographic signal in a human ADME (Absorption, Distribution, Metabolism, and Excretion) study of cadisegliatin— a signal that standard mass spectrometry techniques could not elucidate. To address this, the FDA has mandated an in vitro study to identify and characterize the signal before allowing the program to continue.

Importantly, the clinical hold impacts the CATT1 phase 3 trial, although it is noted that no patients had yet been administered the drug at the time the hold was instituted. Moreover, prior clinical trials of cadisegliatin showed no safety-related issues, adding a layer of reassurance regarding the drug's profile.

Cadisegliatin is an oral medication that targets the liver and acts as a glucokinase activator. This drug has been administered to over 500 individuals, with treatments extending up to six months, and has generally been well-tolerated. The primary function of cadisegliatin is to enhance glucokinase activity in the liver without relying on insulin, thereby aiming to improve blood sugar control through increased hepatic glucose uptake and glycogen storage.

vTv Therapeutics, based in North Carolina, is focused on developing innovative, orally-administered, small molecule drugs aimed at treating chronic illnesses. Cadisegliatin is currently the most advanced candidate in their clinical pipeline and is being developed as a supplementary treatment to insulin for individuals with type 1 diabetes.

While the imposition of the clinical hold is a setback, it is a standard regulatory measure to ensure patient safety and drug efficacy. The company will now focus on conducting the required in vitro study to resolve the FDA's concerns, which, if successful, would allow the cadisegliatin program to move forward.