regulatory
confidence high
sentiment negative
materiality 0.75
FDA places clinical hold on vTv Therapeutics' cadisegliatin Phase 3 trial for type 1 diabetes
vTv Therapeutics Inc.
- FDA clinical hold based on unresolved chromatographic signal in cadisegliatin ADME study.
- FDA requires a single in vitro study to characterize signal before program can resume.
- No patients had been dosed in CATT1 Phase 3 trial at time of hold; no prior safety issues.
- vTv is working with FDA to resolve hold and resume enrollment as quickly as possible.
- Cadisegliatin is an oral glucokinase activator; over 500 subjects dosed to date with favorable safety profile.