vTv Therapeutics cleared to resume clinical trial of diabetes therapy
By Barry Teater | This article originally appeared via NCBiotech's blog
vTv Therapeutics, a biopharmaceutical company based in High Point, has received clearance from the U.S. Food and Drug Administration to resume clinical testing of a potential therapy for type 1 diabetes.
The FDA lifted a clinical hold on the company’s development of cadisegliatin, a first-in-class oral adjunctive therapy for the disease.
The agency in July 2024 halted a Phase 3 trial of the therapy upon the discovery of a chromatographic signal in a human absorption, distribution, metabolism and excretion study of cadisegliatin that could not be resolved by standard mass spectroscopy. The clinical hold was lifted March 14 following submission of a complete response letter by vTv Therapeutics that concluded that the chromatographic signal was an experimental artifact.
No patient had been dosed in the trial at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues, the company said in a news release.
vTv Therapeutics expects to resume its CATT1 clinical trial following the submission of a protocol amendment to the FDA to reduce the trial’s overall duration from 12 months to six months. By shortening the trial, the company said it would be able to obtain topline data from the study more quickly, helping expedite larger pivotal studies required for a future New Drug Application (NDA) submission.
“We are pleased that the FDA has lifted the clinical hold on our cadisegliatin program and are eager to resume our Phase 3 trial,” 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 type 1 diabetes, 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.”
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, founded in 2015, is a clinical-stage company focused on developing novel oral, small-molecule drug candidates for treating chronic inflammatory and metabolic diseases.
Cadisegliatin is the company’s lead drug candidate. Several other products are in earlier stages of development for the treatment of type 1 and type 2 diabetes, glioblastoma, other cancers and additional disorders.
Shares of vTv are traded on the Nasdaq stock exchange under the symbol VTVT.
