FDA Review Initiated for vTv's Phase 3 Cadisegliatin Trial in T1D Patients

vTv Therapeutics, a biopharmaceutical firm dedicated to developing treatments for type 1 diabetes (T1D), has submitted a study protocol to the FDA. The company is initiating its first Phase 3 trial to evaluate the safety and efficacy of cadisegliatin, a potential adjunct to insulin therapy. The trial, set to begin in the second quarter of 2024, will be a randomized, double-blind, placebo-controlled study involving approximately 150 participants across up to 20 U.S. sites.

The primary goal of the Phase 3 study is to compare the frequency of hypoglycemic events in patients treated with cadisegliatin to those receiving a placebo. The trial will focus on individuals already undergoing treatment with multiple daily insulin injections and continuous subcutaneous insulin infusion, along with the use of a continuous glucose monitor (CGM).

In addition to the Phase 3 trial, vTv Therapeutics is also planning a Phase 2 trial for patients with type 2 diabetes, in collaboration with G42 Healthcare Research Technology Projects LLC and IROS, a UAE-based health technology group. This trial is expected to commence in Middle Eastern countries in 2024.

Thomas Strack, MD, PhD, Chief Medical Officer of vTv Therapeutics, emphasized the company's commitment to swiftly confirming the safety and efficacy of cadisegliatin. He noted that the support from institutional investors reflects a pressing need for treatments that can enhance glycemic control and improve the quality of life for individuals with T1D.

Cadisegliatin (TTP399) is an experimental liver-selective glucokinase activator that has been tested in both healthy volunteers and patients with diabetes types 1 and 2. vTv Therapeutics is a clinical-stage company that is developing a range of oral, small molecule drug candidates, with cadisegliatin leading its pipeline.

It is important to note that cadisegliatin has not yet been licensed or approved for use anywhere globally, and its safety and efficacy have not been established. vTv Therapeutics continues its research and development efforts with the aim of providing new treatment options for diabetes management.