When vTv Therapeutics reacquired its ineffective Alzheimer’s drug from Pfizer in 2011, it thought it could produce better results by testing it in a larger group of patients. On Monday, vTv’s gambit proved unsuccessful.
Like so many other Alzheimer’s drugs before it, vTv’s azeliragon failed, taking millions of investor dollars with it. It could not beat a placebo in a Phase 3 study of approximately 800 patients with mild Alzheimer’s disease. In its announcement of the preliminary clinical trial results after markets closed on Monday, the High Point, NC, company said it would now stop work on the drug.
Shares of vTv (NASDAQ: VTVT) sank more than 65 percent to $2.12 in after-hours trading.
An oft-cited 2014 study showed that more than 99 percent of Alzheimer’s drugs failed between 2002 and 2012, and the landscape has only grown worse since then. Recent disappointments include the halt of solanezumab, from Eli Lilly (NYSE: LLY), after that drug failed in Phase 3. Last September, Axovant Sciences (NASDAQ: AXON) announced bad news for its pill, intepirdine. And a similar drug from Lundbeck, idalopirdine, which failed in two Phase 3 studies in early 2017.
It is one of the drug industry’s most dismal track records, made more so by the urgent need to stem the tide of Alzheimer’s, which currently afflicts 5.7 million Americans and extracts a social and financial toll on families and other caregivers.
Azeliragon is a pill developed to target an overabundant protein in the brain tissue of Alzheimer’s patients. The protein—receptor for advanced glycation endproducts, or RAGE—has been studied for its role in Alzheimer’s, including the formation of tau and amyloid proteins. By blocking the receptor, the company hoped to slow the progression of Alzheimer’s in patients with mild to moderate forms of the disease.
Pfizer (NYSE: PFE) licensed azeliragon in 2006 from TransTech Pharma, the previous name of vTv. But after an interim analysis of a mid-stage study concluded that azeliragon was unlikely to be better than a placebo, Pfizer stopped work on the drug and returned rights to TransTech in 2011.
TransTech changed its name to vTv then raised $117 million in a 2015 initial public offering which would mainly pay for Phase 3 studies.
The vTv studies, dubbed STEADFAST, enrolled patients in two identical, randomized, double-blind, placebo-controlled trials, A and B. According to early clinical trial results, patients in the group A study showed improvement in cognitive function, which was the main goal. But vTv said the improvement wasn’t statistically significant—that is, enough to be better than the placebo group by more than just random chance. On a secondary goal of the study, patients treated with the drug scored the same as those given a placebo.
In a prepared statement, vTv CEO Steve Holcombe said that the company will analyze data from both of its test groups to determine if there are other uses for azeliragon. VTv also has other compounds in its pipeline, including two diabetes drugs in mid-stage trials.
—Image by Depositphotos.