Another day, another Alzheimer's treatment bites the dust. This time, it's vTv Therapeutics' azeliragon, which missed both of its co-primary endpoints in a phase 3 trial of patients with mild Alzheimer's.
The treatment failed to beat out placebo in improving cognitive or functional outcomes measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb), the company said in a statement. In fact, the treatment group posted a worse decline in ADAS-Cog than the placebo group—4.4 versus 3.3 points from baseline—while the decline in CDR-sb score was identical for both groups. vTv plummeted 66% in after-hours trading.
The company is now ditching all ongoing clinical studies of azeliragon but expects a "substantial number" of patients in an identical phase 3 trial to have completed 12 months of treatment under the study protocol. vTv will be taking a good look at the data from both trials in the coming weeks, the company said.
“We will continue to analyze the data sets 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 CEO Steve Holcombe in the statement. “On behalf of vTv Therapeutics, we’d like to extend our most sincere and heartfelt gratitude to study participants, their families, physicians and caregivers for their commitment to this important study.”
In July 2015, vTv priced its IPO at $117 million, at the low end of the range. It had hoped to raise more than $150 million. It built its case around azeliragon, a Pfizer castoff that failed several midstage trials as a solo therapy but showed promise in combination with Aricept.
Azeliragon is just the latest Alzheimer's drug to crash and burn in phase 3. In February, Merck pulled the plug on a phase 3 trial of its BACE1 inhibitor verubecestat in prodromal Alzheimer's after an interim review. And the study halt came after the Big Pharma had already ended a trial in patients with more advanced forms of the disease after seeing similarly lackluster data.