vTv Therapeutics announces initiation of Phase 2 azeliragon study
vTv Therapeutics announced that the first patient has been screened for the phase 2 proof of concept study evaluating the safety and efficacy of azeliragon in patients with mild Alzheimer's disease and type 2 diabetes. In a post hoc analysis of the phase 3 STEADFAST trial, a subgroup of patients with mild Alzheimer's disease and type 2 diabetes who were treated with azeliragon demonstrated a potential benefit in both cognition and function, less brain atrophy and glucose utilization and decreases in inflammatory biomarkers compared to the same subgroup of patients treated with placebo. This randomized, double-blind, placebo-controlled, multicenter trial consists of sequential phase 2 and phase 3 studies operationally conducted under one protocol. Each part of the study will evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease. The six-month phase 2 study is designed to enroll approximately 100 patients randomized to either azeliragon 5 mg/day or placebo with the primary endpoint of change from baseline at month 6 in ADAS-cog14. The 18-month phase 3 study, to be initiated following top line results from the phase 2 study, is currently designed to enroll approximately 200 patients with co-primary endpoints of change from baseline at month 18 in cognition and function, subject to modification based upon the phase 2 results. vTv expects to report topline results from the phase 2 proof of concept study by the end of Q4 of 2020.