The novel, investigational treatment for mild Alzheimer’s disease, azeliragon (TTP488; vTv Therapeutics), did not meet its co-primary endpoints in the STEADFAST Phase 3 clinical trial. As a result, vTv Therapeutics announced today that they would be discontinuing the open-label extension study and Part B of the STEADFAST study.

Azeliragon, a novel orally active small-molecule antagonist of receptor for advanced glycation endproducts (RAGE), was developed by the Company using its propriety drug discovery platform, TTP Translational Technology. The STEADFAST study was comprised of 2 independent and identical (Part A, Part B), randomized, double-blind, placebo-controlled trials that enrolled 400 patients each. 

Results showed that after 18-months, there was no significant statistical difference in cognitive or functional outcomes between those patients taking azeliragon and those in the placebo group. Cognitive outcomes were measured by the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb). 

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In Part A, declines in ADAS-Cog from baseline were 4.4 and 3.3 for the azeliragon and placebo group, respectively. The CDR-sb scores showed declines of 1.6 for both groups. Although the Company has discontinued Part B, with a substantial portion of individuals having already completed 12 months of treatment, they stated that they will continue to evaluate data from Part B and also from Part A in the coming weeks. 

“We will continue to analyze the datasets and trends within subgroups from both Part A and Part B to determine if there are potential benefits or future uses and applications for azeliragon,” said Steve Holcombe, chief executive officer, vTv Therapeutics.

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