1 July 2019 - - 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, US-based vTv Therapeutics Inc. (NASDAQ: VTVT) said.
In a post hoc analysis of the phase 3 STEADFAST trial, a subgroup of patients with mild Alzheimer's disease and type 2 diabetes (defined by glycosylated hemoglobin (HbA1c) of greater than 6.5% at any time during the study) who were treated with azeliragon demonstrated a potential benefit in both cognition and function, less brain atrophy and glucose utilisation, and decreases in inflammatory biomarkers compared to the same subgroup of patients treated with placebo.
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This randomised, 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 (screening MMSE 21 to 26, baseline MMSE 19 to 27; and ADAS-cog14 score ≥10) and type 2 diabetes (screening HbA1c 6.5% to 9.5%, inclusive).
The six-month phase 2 study is designed to enroll approximately 100 patients randomised 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 the fourth quarter of 2020.
Azeliragon, also known as TTP488, is an orally active small-molecule antagonist of the receptor for advanced glycation endproducts, RAGE.
vTv Therapeutics discovered and developed azeliragon using its proprietary drug discovery platform, TTP Translational Technology.
A range of human pathologic and experimental biologic investigation suggests that RAGE ligand interactions lead to sustained inflammatory states that play a role in chronic diseases such as diabetes, inflammation, and Alzheimer's disease.
vTv Therapeutics Inc. is a public, clinical-stage biopharmaceutical company engaged in the discovery and development of orally administered small molecule drug candidates to fill significant unmet medical needs. vTv has a pipeline of clinical drug candidates led by programs for the treatment of diabetes, Alzheimer's disease, and inflammatory disorders.