Cannot help but be disappointed for these patients.
disease did not meet either co-primary efficacy endpoint
The STEADFAST study is comprised of two independent and identical randomized, double-blind, placebo-controlled Phase 3 trials (Part A and Part B). 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.
The bar cannot be set any lower can it? They spent a Lot of time, money, stress and sweat. Maybe AVXL can produce something that will give these folks some future hope.