It is looking likely that another late-stage candidate for Alzheimer’s disease will fail to make it past Phase III trials, with vTv Therapeutics’ experimental therapy the latest in a long line to miss its targets.
The US biotech said that patients taking azeliragon in the Phase III STEADFAST trial failed to demonstrate a significant improvement in cognitive or functional outcomes over the placebo group.
The STEADFAST study is comprised of two independent and identical placebo-controlled 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, though the difference was not stastically significant.
On the plus side, the therapy was generally well-tolerated with a 25 percent withdrawal rate over 18 months that was similar in both the placebo and treatment arms, the firm noted.
vTv Therapeutics said it will discontinue current clinical studies involving azeliragon, including the open-label extension study and Part B of the STEADFAST study.
However, as a “substantial portion” of patients in Part B will have completed 12 months of treatment under the study protocol, the company will “continue to thoroughly evaluate subset data” over the coming weeks.
“We will continue to analyse 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.
The company’s stock reportedly dropped as much as 70 percent as investors reacted to the news.