On 15 December, vTv Therapeutics, a clinical-stage pharmaceutical company focused on the development of human therapeutics to fill unmet medical needs, announced top-line results from its Phase II trial of azeliragon in people with mild Alzheimer’s disease (AD) and type 2 diabetes. Azeliragon is an oral small molecule inhibitor of RAGE (receptor for advanced glycation end products), which is thought to promote inflammation and amyloid beta deposition in the brain.
The Elevage Phase II study is a randomised, double-blind, placebo-controlled, and multicenter trial evaluating the safety and efficacy of azeliragon in people with mild AD and impaired glucose tolerance in US and Canada.
The company reported that the trial did not meet its primary objective of demonstrating an improvement in cognition as assessed by the 14-item Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-cog14) relative to placebo. Results from the 6-month trial showed that the azeliragon treated group had a decline from baseline in ADAS-cog14 compared to the placebo group, however these differences were not statistically significant. These findings include data from 43 participants with mild probable AD and type 2 diabetes who received either azeliragon (5mg) or placebo orally once daily.
“We will continue to analyze the data to determine if there are potential benefits or future applications for azeliragon in Alzheimer’s, dementia or related indications that we or other interested parties may seek to pursue, said Steve Holcombe, chief executive officer”, vTv Therapeutics.
