vTv Therapeutics Announces Topline Results from Part B of Phase 3 STEADFAST Study

vTv Therapeutics (Nasdaq:VTVT) today announced that results from Part B of the Company’s STEADFAST Study of the investigational medication azeliragon in people with mild Alzheimer’s disease did not meet co-primary efficacy endpoints.

As quoted in the press release:

The prespecified subgroup consisted of azeliragon-treated patients with maximal azeliragon plasma concentrations of less than 7.5 ng/mL and baseline Mini Mental State Examination (MMSE) scores between 19 and 27, and the endpoints were statistically significant improvement in cognitive or functional outcomes as measured by the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) and Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) at 12-months compared to placebo.

However, consistent with findings in Part A and the Phase 2b trial, lower maximal plasma concentrations of azeliragon in Part B were associated with improvements in efficacy relative to placebo. For example, when pooling the results of Part A and Part B and comparing change from baseline at 12 months, the azeliragon subgroup (n=88) had a 1.8 point improvement in ADAS-cog, a 0.4 improvement in CDR-sb and a 2.3 improvement in Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) relative to placebo (n=373).

Click here to read the full press release.