vTv Therapeutics Inc, a late stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, announced that the first patient has been screened in the Company’s CATT1 pivotal trial evaluating cadisegliatin as an adjunct treatment of type 1 diabetes. CATT1 is designed to be a registrational study and is one of several trials that will form the core of the regulatory submission for cadisegliatin, a potential first-in-class, oral, liver selective, glucokinase activator for T1D that has been dosed in over 500 subjects to date, including 300 patients with T1D and type 2 diabetes (T2D).
“Maintaining glycemic control remains a high and burdensome unmet need for the nearly 8 million people with T1D worldwide. Cadisegliatin is a new approach to current standards of care that is designed to regulate blood glucose levels by selectively activating glucose pathways in the liver,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. “Screening the first patient marks an important milestone for our late stage cadisegliatin program and brings us closer to our mission of delivering novel treatments that help improve the lives of millions of patients living with diabetes.”
Dr. Thomas Strack, Chief Medical Officer of vTv Therapeutics added, “85% of patients with T1D experience one or two hypoglycemic episodes every week, representing an important barrier that limits optimal treatment. Cadisegliatin is designed to reactivate the glucose-regulating capacity in the liver independent of insulin to safely improve episodes of hyper- and hypoglycemia in patients with diabetes.”
CATT1 is a randomized, double-blind, placebo-controlled pivotal study evaluating the efficacy and safety of cadisegliatin over 12 months in adults 18 years or older diagnosed with T1D. The trial is expected to enroll approximately 150 patients at up to 20 sites in the U.S. Two doses of orally administered cadisegliatin versus placebo will be assessed in patients currently being treated with multiple daily insulin injections and continuous subcutaneous insulin infusion who use a continuous glucose monitor. The primary efficacy endpoint of the study will compare the incidence of Level 2 or Level 3 hypoglycemic events between cadisegliatin-treated subjects and those in the placebo group.
Cadisegliatin will also be evaluated as an adjunctive therapy to insulin in patients with T2D as part of a planned Phase 2 trial in Middle Eastern countries in collaboration with G42 Healthcare Research Technology Projects LLC and its clinical research organization IROS, a UAE-based health technology group which is expected to start in the second half of 2024.
SOURCE: GlobeNewswire