The regulator requested a single in vitro study to characterise this signal before the clinical programme for type 1 diabetes can continue. Credit: PeopleImages.com – Yuri A / Shutterstock.

The US Food and Drug Administration (FDA) has placed a hold on vTv Therapeutics’ cadisegliatin clinical programme.

The clinical hold was placed following the identification of an unresolved chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin.

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It includes the pause of the ongoing Phase III CATT1 trial for type 1 diabetes.

Cadisegliatin has been administered to more than 500 subjects with a good tolerance record for up to six months of treatment.

The US regulator requested a single in vitro study to characterise this signal before the clinical programme can continue.

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No patients had received dosing in the CATT1 trial at the time of the clinical hold, and previous clinical studies have not indicated any safety concerns of clinical significance.

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Recently, the company screened the first subject in the CATT1 trial of cadisegliatin as an adjunct T1D treatment.

CATT1 is a registrational study and is one among the many trials that will act as a base for the regulatory submission for cadisegliatin.

Also known as TTP399, cadisegliatin is a new, orally administered small molecule that selectively activates glucokinase in the liver.

By acting on the liver, the therapy is designed to improve glycemic control through enhanced hepatic glucose uptake and increased glycogen storage independently of insulin.

vTv Therapeutics chairman, president and CEO Paul Sekhri said: “Patient safety is our top priority, and we appreciate the thoroughness of the FDA to better understand this signal. We are working diligently with the agency to resolve the clinical hold and resume enrollment as quickly as possible.

“Cadisegliatin demonstrated compelling efficacy and a favourable safety profile in over 500 subjects dosed to date, and we are highly encouraged at the potential of cadisegliatin to improve glycemic control and be a much-needed oral therapy for type 1 diabetes.”