In Alzheimer’s, failure seems to spring eternal, but that doesn’t mean you can’t find something to sell to investors.
We already know that vTv Therapeutics $VTVT racked up one of the latest failures in Alzheimer’s research after its lead drug — azeliragon — failed the first part of a pivotal study. Now it is conceding that Part B was also a failure on both endpoints, but it’s asking investors to keep the faith as they extract signs of success they hope to use to get back into the clinic.
In this case, that something is a subgroup analysis for patients with lower maximal plasma concentrations of azeliragon. There, researchers extracted positive data.
Investors weren’t buying it, though. The stock dropped 27% in after-market trading.
“We are eager to obtain early feedback from the FDA based on the results we have achieved and the data that we have observed associating lower plasma levels of the drug and improved efficacy,” said Steve Holcombe, chief executive officer, vTv Therapeutics. “As a result, we believe that azeliragon has the potential to address the pressing unmet need in Alzheimer’s disease.”
In Part A the drug 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.
Their drug — recycled after a past flop — targets the receptor for advanced glycation endproducts — “RAGE” — and about 800 patients were enrolled for the Phase III program under a special protocol assessment struck with the FDA.
This is the second round of failure for a pivotal Alzheimer’s study in one day, something of a record for a disease which has so far defeated every attempt to rein it in for more than a decade. Eli Lilly and AstraZeneca were more forthright in their failure, packing it in after the second big BACE program in the clinic collapsed on bad results. You likely won’t find it back in the clinic – unlike vTv which wants one more swing at the big one.
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