On 27 June, vTv Therapeutics announced that they had initiated recruitment of patients with mild alzheimer’s disease (AD) and type 2 diabetes to a new Phase II proof-of-concept trial of azeliragon.
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. Although the recent STEADFAST Phase III trial of azeliragon in AD failed to reach its co-primary endpoints, a post-hoc subgroup analysis of cognitive and functional measures showed positive effects in patients with type 2 diabetes and AD.
Based on these encouraging results, vTv Therapeutics are aiming to recruit around 100 patients with AD and type 2 diabetes (defined as an HbA1c level of 6.5 – 9.5%) to their Phase II placebo-controlled study of azeliragon. If safety and efficacy endpoints are met within the 6-month timeframe of this study, vTv Therapeutics will progress to a larger-scale Phase III trial. Top-line results from the Phase II proof-of-concept trial are expected towards the end of 2020.
