vTv Therapeutics STEADFAST study misses both endpoints, study to be discontinued
vTv Therapeutics announced that results from part A of the company's Phase 3 STEADFAST study of the investigational medication azeliragon in people with mild Alzheimer's disease did not meet either co-primary efficacy endpoint. Patients taking azeliragon compared with placebo did not improve in cognitive or functional outcomes as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale, or ADAS-cog, and the Clinical Dementia Rating Scale Sum of Boxes, or CDR-sb. The STEADFAST study is comprised of two independent and identical randomized, double-blind, placebo-controlled Phase 3 trials. The azeliragon treated group in part A had a 4.4 point decline from baseline in ADAS-Cog and a 1.6 point decline from baseline in CDR-sb compared to a placebo decline of 3.3 and 1.6 respectively. These differences were not statistically significant. Azeliragon was generally well-tolerated with a 25% withdrawal rate over 18 months that was similar in both the placebo and treatment arms. vTv Therapeutics is discontinuing current clinical studies involving azeliragon, including the open-label extension study and Part B of the STEADFAST study. Given the progress to date of STEADFAST Part B, the company expects that a substantial portion of the patients in Part B of STEADFAST will have completed 12 months of treatment under the study protocol. vTv Therapeutics will continue to thoroughly evaluate subset data from Part A and then the dataset from Part B over the coming weeks.