vTv Therapeutics Begins CATT1 Trial for Cadisegliatin in Type 1 Diabetes

A significant development in diabetes treatment was announced by vTv Therapeutics Inc., a late-stage biopharmaceutical company. The company revealed that it has begun screening the first patient in its pivotal CATT1 trial, which will assess the efficacy of cadisegliatin as an adjunct therapy for type 1 diabetes (T1D). This marks a critical phase for cadisegliatin, a novel, oral, liver-selective glucokinase activator.

Cadisegliatin represents a new approach in managing T1D by targeting glucose regulation in the liver, aiming to maintain glycemic control more effectively. The drug has been administered to over 500 subjects, including 300 patients with diabetes, revealing its potential to become a breakthrough in diabetes treatment. The U.S. FDA has already granted it Breakthrough Therapy designation for T1D.

Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics, emphasized the pressing need for better glycemic control among the nearly 8 million people worldwide suffering from T1D. He highlighted that cadisegliatin aims to improve the regulation of blood glucose levels by targeting glucose pathways in the liver. Screening the first patient in the CATT1 trial is a significant step toward vTv's goal of providing innovative treatments for patients with diabetes.

Dr. Thomas Strack, Chief Medical Officer at vTv Therapeutics, pointed out the frequent hypoglycemic episodes experienced by T1D patients, noting that 85% of these patients encounter one or two such episodes weekly. These episodes pose significant barriers to optimal diabetes management. Cadisegliatin is designed to enhance the liver's glucose-regulating function independently of insulin, potentially reducing both hyperglycemia and hypoglycemia episodes.

The CATT1 trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety and efficacy of cadisegliatin over a period of 12 months. The trial will involve approximately 150 T1D patients aged 18 or older across up to 20 sites in the United States. Participants will be administered one of two doses of cadisegliatin or a placebo while continuing their existing insulin therapies. The primary endpoint of the study will be the comparison of Level 2 or Level 3 hypoglycemic events between the treatment and placebo groups.

Additionally, cadisegliatin will be tested as an adjunctive therapy for type 2 diabetes (T2D) in a planned Phase 2 trial. This trial is slated to begin in the second half of 2024 in Middle Eastern countries, in partnership with G42 Healthcare Research Technology Projects LLC and IROS, a UAE-based health technology group.

Cadisegliatin (TTP399) is a pioneering oral small molecule that selectively activates glucokinase in the liver. By enhancing the activity of glucokinase independently of insulin, it aims to improve glycemic control through increased hepatic glucose uptake and glycogen storage.

vTv Therapeutics Inc. is dedicated to developing oral, small molecule drug candidates. Their clinical pipeline is led by cadisegliatin, which shows potential as an adjunctive therapy to insulin for T1D management. Additionally, vTv and its partners are exploring the application of cadisegliatin for T2D and other chronic conditions, aiming to provide new solutions for diabetes patients globally.