FDA Places Clinical Hold on vTv Therapeutics’ Diabetes Drug Program

1. Clinical Hold: The FDA has placed a clinical hold on vTv Therapeutics' Phase 3 trial for cadisegliatin, an oral small molecule candidate for type 1 diabetes treatment.
2. Reason for Hold: The hold was triggered by an unresolved chromatographic signal identified in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin.
3. Impact on Trial: The ongoing Phase III CATT1 trial for type 1 diabetes has been paused, although no patients had received dosing at the time of the hold.
4. Previous Studies: Cadisegliatin has been administered to over 500 subjects with a good tolerance record for up to six months of treatment, showing no safety concerns of clinical significance.
5. Company Response: vTv Therapeutics is working with the FDA to resolve the issue and resume enrollment as quickly as possible, emphasizing patient safety as their top priority.