vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes (“T1D”), today announced the submission of the study protocol to the FDA for the Company’s first Phase 3 trial evaluating the safety and efficacy of its lead candidate, cadisegliatin, in adults diagnosed with T1D.
This randomized, double-blind, placebo-controlled trial is expected to enroll approximately 150 patients at up to 20 sites in the United States, with the first patient expected to be enrolled in the second quarter of 2024.
The Phase 3 study will assess two doses of orally administered cadisegliatin versus placebo in patients currently being treated with multiple daily insulin injections and continuous subcutaneous insulin infusion, who use a continuous glucose monitor (CGM). 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.
This trial further expands vTv’s research into cadisegliatin as an adjunctive therapy to insulin, which also includes a planned Phase 2 trial in patients with type 2 diabetes expected to start in Middle Eastern countries in 2024 in collaboration with vTv’s partner G42 Healthcare Research Technology Projects LLC and its clinical research organization IROS, a UAE-based health technology group.
“vTv’s primary focus is on expeditiously confirming the safety and efficacy of cadisegliatin, and this initial Phase 3 trial will help provide a more robust body of clinical evidence on the drug’s profile in a relatively short timeframe. The ongoing support from institutional investors who participated in our recent private placement reflects the urgent need for treatments that improve glycemic control and have a positive impact on the quality of life of patients with T1D,” said Thomas Strack, MD, PhD, Chief Medical Officer, vTv Therapeutics.
Cadisegliatin is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use.
