FDA Halts vTv Therapeutics’ Type-1 Diabetes Clinical Trial Due to Chromatographic Signal

Clinical Hold:
The FDA has placed a hold on vTv Therapeutics' Phase 3 clinical trial for cadisegliatin, a drug intended to treat type-1 diabetes, due to an unresolved chromatographic signal discovered in a recent human absorption, distribution, metabolism, and excretion (ADME) study.

Drug Details:
Cadisegliatin is an orally administered, liver-selective glucokinase activator that enhances glycemic control by increasing hepatic glucose uptake and glycogen storage independently of insulin.

Patient Safety:
No patients had been dosed in the CATT1 trial at the time of the clinical hold, and previous studies have not revealed any significant safety concerns.

Regulatory Requirement:
The FDA has mandated a single in vitro study to characterize the chromatographic signal before the clinical program can resume.

Company Response:
vTv Therapeutics is working diligently with the FDA to resolve the issue and resume enrollment as quickly as possible, emphasizing that patient safety is their top priority.

Financial Impact:
The news led to a significant drop in vTv Therapeutics' share price, plummeting by as much as 44% on the day of the announcement.

Clinical Background:
Cadisegliatin has been well-tolerated in over 500 subjects, including at least 300 patients with diabetes, with up to six months of treatment.