Little vTv once again circles subgroup number, struggling to find something good to say about failed Alzheimer's drug
The biotech vTv raised $117 million from their 2015 IPO $VTVT based on a pitch that they could take a failed Alzheimer’s drug from Pfizer and follow a trail of positive subset data to a big win. That didn’t work, with Phase A of the pivotal program failing both co-primary endpoints recently.
In fact, the drug arm once again did worse than a placebo group.
But now they’ve had a chance to do some post hoc analysis of the first round of Phase III data, and they’re back to spotlighting a positive batch of data for a subpopulation.
So here it is. In a statement out Wednesday night, vTv says that a group of patients with a concentration of the drug azeliragon under a bar of 7.5 ng/mL hit a statistically significant score for ADAS-cog, p=0.02. It failed on another score — CDR-sb — with a p-value of 0.06. And they want to revise their statistical analysis plan for the FDA.
The subgroup included 48 of the 400 patients in the study, which was divided between the drug and a placebo.
The biotech’s shares — which were crushed on the initial Phase III failure — bounced higher in pre-market trading Thursday. Whether they can sustain that with additional subgroup analysis remains to be seen, but vTv is once again going down a path that has led to the destruction of billions of dollars of investors’ cash on a wide range of drug studies.
The company designed the 18-month Phase III program based on data that the small 5 mg dose of the drug performed well in Pfizer’s study, where the 20 mg failed. And just like about everything else in the Alzheimer’s pipeline, that strategy has proved to be a repeat loser.
Investors in the field keep buying into the idea that acquiring shares in an Alzheimer’s stock is just like buying lottery tickets — ultra high risk with the possibility of ultra high rewards. But with no winners in more than a decade, that argument has been wearing thin.
This biotech, though, is still determined to keep rolling the dice.
“We are encouraged by the positive improvements in cognitive and functional outcomes relative to placebo based upon low azeliragon concentration levels,” said vTv CEO Steve Holcombe in a statement. “With this understanding, we are continuing to analyze the data and then plan to examine the relevant population prospectively in the Part B study and announce results in June.”