vTv Therapeutics Inc. (NASDAQ:VTVT) has announced its Q3 financial results and provided updates on its clinical programs.
vTv completed enrolment in Elavage study of azeligaron
The company’s CEO, Steve Holcombe, said that the company completed enrolment in the Elevage Study at the end of September. He said that the company is looking forward to announcing topline results from the Phase 2 Elevage study of azeligaron. Holcombe said that the company is planning a mechanistic TTP399 study at the beginning of 2021 to understand its effect on diabetic ketoacidosis. The CEO added that the company is also planning a phase 1 study HPP737, its PDE4 inhibitor compound, as the first step towards a psoriasis proof-of-concept study. vTv Therapeutics will report topline data from the phase 1 HPP737 study and the mechanistic TTP399 study in Q2 2021.
vTv Therapeutics continued discussions with the FDA during the third quarter regarding the design and endpoints of the planned TTP399 studies as an Insulin therapy adjunct for Type 1 diabetes. The company received positive feedback from the agency, and it is now planning to carry out a six-month placebo-controlled clinical study in 400 subjects. Also, another placebo-controlled study will follow after the commencement of the first clinical trial.
vTv to commence mechanistic ketoacidosis study evaluating TTP399
The company is developing a mechanistic ketoacidosis study to support the hypothesis that TTP399 can reduce ketoacidosis incidence. vTv will conduct the study in a section of Type 1 diabetes patient to determine TTP399’s impact on ketone body formation during acute insulin withdrawal. The FDA recommended that the company conducts the study in support of planned vital studies. The mechanistic study will commence in Q1 2021, and topline results will be available in Q2 2021.
At the end of September, the company completed enrolment in Phase 2 Elevage trial of azeliragon. The study recruited 43 patients with Type 2 diabetes and mild probable Alzheimer’s disease. vTv will evaluate the effect of azeligaron treatment in six months on cognitive performance. Topline data will be available in December 2020.