vTv Therapeutics Inc.

vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing orally administered therapies for metabolic and inflammatory diseases. The company's primary goal is to improve patient outcomes. Its lead product candidate is cadisegliatin (TTP399), a novel, small-molecule, liver-selective glucokinase activator (GKA). Cadisegliatin is currently in a Phase 3 clinical trial, known as the Cadisegliatin as Adjunctive Therapy to Insulin in Participants with Type 1 Diabetes ("CATT1") trial. This trial is evaluating cadisegliatin as a potential oral adjunctive therapy to insulin for the treatment of type 1 diabetes (T1D). The CATT1 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study designed to assess cadisegliatin's effect on hypoglycemia outcomes in T1D patients. The primary endpoint is the reduction in the frequency of Level 2 hypoglycemia (blood glucose <54 mg/dL) and Level 3 (severe) hypoglycemia over a six-month treatment period. A key secondary endpoint is the change in hemoglobin A1c (HbA1c), a standard measure of glycemic control, to evaluate cadisegliatin's potential to reduce hyperglycemia. The CATT1 trial will randomize 150 patients with T1D on a 1:1:1 basis, with 50 patients per study arm, to receive either 800 mg cadisegliatin daily, 800 mg cadisegliatin twice daily, or placebo. In 2021, the FDA granted Breakthrough Therapy designation for cadisegliatin as an adjunctive therapy to insulin for the treatment of T1D. This designation aims to expedite the development and review of drugs for serious conditions where preliminary clinical evidence suggests substantial improvement over available therapies on clinically significant endpoints. The Breakthrough Therapy designation for cadisegliatin in T1D was supported by positive results from the Phase 2 SimpliciT-1 Study. This multi-center, randomized, double-blind, adaptive study assessed the safety and efficacy of cadisegliatin as an adjunct to insulin therapy in adults with T1D. In that trial, cadisegliatin treatment led to a clinically meaningful 40% decrease in the frequency of severe and symptomatic hypoglycemia and a statistically significant improvement in HbA1c relative to placebo. Cadisegliatin also demonstrated a favorable safety profile, with abnormal levels of serum or urine ketones detected less frequently in patients taking cadisegliatin compared to those taking placebo.