vTv's azeliragon misses Alzheimer’s endpoint

vTv Therapeutics Inc. (NASDAQ:VTVT) said it will discontinue clinical trials of azeliragon (TTP488) after the Alzheimer’s disease candidate missed the co-primary endpoints in Part A of the Phase III STEADFAST trials to treat mild AD. The company, which announced the news after market hours on Monday, lost $2.16 (66%) to $1.10 in after-hours trading.

STEADFAST comprises two independent and identical Phase III trials -- Part A and Part B -- in a total of 800 patients who received once-daily 5 mg oral azeliragon or placebo for 18 months. On Part A's co-primary endpoints, azeliragon led to a 4.4-point decline in AD Assessment Scale-Cognitive Subscale (ADAS-Cog) score and a 1.6-point decline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) score from baseline to 18 months vs. declines of 3.3 and 1.6 points, respectively, for placebo (p=not significant for both)...