vTv Therapeutics' Cadisegliatin Program for Type 1 Diabetes on Clinical Hold

HIGH POINT, N.C., July 26, 2024 – vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company specializing in innovative clinical solutions, announced that the United States Food and Drug Administration (FDA) has placed a clinical hold on its cadisegliatin program, which includes the ongoing CATT1 Phase 3 trial for type 1 diabetes. Cadisegliatin is an oral glucokinase activator, targeting the liver and has been administered to over 500 subjects for up to six months with good tolerance.

The clinical hold follows the discovery of a chromatographic signal in a recent ADME study of cadisegliatin, which could not be identified using standard mass spectroscopy techniques. The FDA requires a single in vitro study to further characterize this signal before continuing the cadisegliatin program. No patients had been dosed in the CATT1 trial at the time of the hold, and previous clinical studies revealed no significant safety concerns.

Paul Sekhri, Chairman, President, and Chief Executive Officer of vTv Therapeutics, emphasized the company's commitment to patient safety and collaboration with the FDA to address the issue promptly. Sekhri expressed optimism about cadisegliatin's potential to enhance glycemic control and serve as an important oral treatment option for type 1 diabetes, citing its demonstrated efficacy and favorable safety profile in previous studies involving over 500 subjects.

Cadisegliatin, also known as TTP399, is a novel oral small molecule that selectively activates glucokinase in the liver, improving glycemic control by enhancing hepatic glucose uptake and glycogen storage independently of insulin. This first-in-class potential treatment aims to serve as an adjunct therapy for individuals with type 1 diabetes.

vTv Therapeutics Inc. remains focused on developing novel oral small molecule drug candidates to address chronic diseases. The company's clinical pipeline is spearheaded by cadisegliatin, which holds promise as an adjunctive therapy to insulin for type 1 diabetes.

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