The biotech, which floated an IPO on the back of an idea that it could take a failed drug from Pfizer and make it work based on some retrospective data analysis (sound familiar?), reported Monday afternoon that their lead therapy azeliragon failed a Phase III study for mild to moderate Alzheimer’s.
The failure was complete, flopping on both cognition and function, the current gold standard for an approval that has remained elusive in this field. The drug arm actually did worse than the placebo group. The company statement noted:
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.
Unexpected? To the contrary. Practically everything thrown at Alzheimer’s over the last 15 years has failed in pivotal studies. And the latest company to try this tack with a discard, Axovant, was crushed by its own recent failure. The execs at vTv can now join that crowd. The biotech’s shares crashed Monday evening, eviscerating value in a 66% plunge.
The biotech went public close to three years ago at $15 a share, raising $117 million to pay for this Phase III. It’s been floundering ever since, ending Monday evening at $1.14 a share in after-market trading.
Their drug 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.
The biotech actually isn’t finished yet, hoping that it can find some sign of success. It’s unlikely anyone will pay much attention if they do.
“We will continue to analyze 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 vTv CEO Steve Holcombe in a statement.
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