FDA Lifts Clinical Hold On vTv Therapeutics' Phase 3 Diabetes Trial, Stock Surges

On Monday, the U.S. Food and Drug Administration (FDA) lifted the clinical hold on vTv Therapeutics Inc.’s VTVT cadisegliatin clinical program.

The program includes the CATT1 Phase 3 trial in type 1 diabetes (T1D).

Cadisegliatin is an oral, liver-selective glucokinase activator that has been generally well tolerated in over 500 subjects to date with up to six months of treatment.

vTv Therapeutics expects to resume the trial following the submission of a protocol amendment to reduce the overall duration of the CATT1 trial from 12 months to 6 months. This will help expedite the initiation of required larger pivotal studies for future New Drug Application (NDA) submissions.

Also Read: Microchip Launches E2W Ecosystem To Boost Efficiency And Safety In Electric Scooters

The original primary endpoint of ascertaining level 2 and 3 hypoglycemia rates at 6 months will not change.

The planned amendment will not include the additional 6-month period to collect safety data. By shortening the trial from 12 to 6 months, the company will be able to obtain topline data from the study more quickly.

“We are pleased that the FDA has lifted the clinical hold on our cadisegliatin program and are eager to resume our Phase 3 trial. Importantly, we plan to submit a protocol amendment to reduce the time to topline data by 6-months, which will allow us to initiate our larger Phase 3 studies sooner to support our future NDA submission,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics.

“Cadisegliatin has the potential to be the first oral adjunctive therapy to insulin for T1D and we look forward to further evaluating the effects of cadisegliatin on glycemic control and incidence of hypoglycemia over insulin alone after reinitiating the CATT1 Phase 3 trial.”

In July 2024, the FDA placed a clinical hold on the cadisegliatin clinical program.

The clinical hold was based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy.

The agency requires a single in vitro study to characterize this signal before the cadisegliatin program can resume.

Price Action: VTVT stock is up 66.70% at $24.76 at the last check Monday.

Read Next: