Shares of vTv Therapeutics Inc. (NASDAQ: VTVT) are on a significant surge today following the lifting of a clinical hold on a key trial. As of the most recent market check, VTVT stock was soaring 64.75%, trading at $24.42.
FDA Clears Cadisegliatin Clinical Program
The FDA has removed the clinical hold on vTv Therapeutics’ cadisegliatin clinical program, which includes the CATT1 Phase 3 study for type 1 diabetes (T1D), the company stated. Cadisegliatin is a liver-selective glucokinase activator that is taken orally. It has been shown to have good tolerability in more than 500 patients, and therapy can last up to six months.
After a chromatographic signal was found in a human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin, the regulatory hold was first put in place on July 26, 2024. The trial was temporarily halted due to this abnormality, which was not resolvable with conventional mass spectroscopy methods.
Resolution and Resumption of the Trial
At the time of the clinical hold, no patients had been administered doses in the CATT1 trial, and prior clinical investigations had not identified any safety concerns. Following an extensive review, vTv Therapeutics submitted a comprehensive response letter, concluding that the chromatographic signal was an experimental artifact. As a result, on March 14, 2025, the FDA formally removed the hold.
With a revised protocol, vTv Therapeutics now intends to restart the study with a shorter period of six months instead of twelve. The purpose of this modification is to expedite the production of topline data and make it easier to begin bigger pivotal studies that are required for a subsequent New Drug Application (NDA) filing.
There will be no changes to the primary endpoint, which evaluates level 2 and level 3 hypoglycemia rates at six months. However, the extended six-month safety data collection period will be omitted.
Possible Advancement in the Management of Diabetes
With the restart of the CATT1 study, vTv Therapeutics is still assessing how well cadisegliatin works with insulin treatment to improve glycemic control and lower the incidence of hypoglycemia. If cadisegliatin is effective, it may be the first oral adjunctive medication for type 1 diabetes, which would represent a major improvement in the treatment of the disease.
