Results, Setbacks

Axovant: That positive p-value we reported yesterday? Um, we screwed that up too

Yesterday Axovant execs watched their stock price $AXON collapse after the biotech founded by the youthful former hedge fund manager Vivek Ramaswamy was forced to concede that its lead drug was worthless.

David Hung

Today, the company led by CEO David Hung followed up with the extraordinarily embarrassing admission that it managed to incorrectly report the p value for the one clearly positive endpoint they had touted as a sign that the biotech’s second drug, nelotanserin, was worthy of a pivotal trial.

Instead of mining a positive endpoint from the data on nelotanserin, post hoc, they had another fail to explain. And it was bad.

Tuesday morning Axovant put out a release that their post-hoc subset analysis of Parkinson’s patients with a baseline SAPS-PD score greater than 8.0 (n=19) showed that a 40 mg for two weeks followed by 80 mg for two weeks did indeed result in a 1.21 point improvement.

But…

That p=0.011 figure they posted was wrong. In fact, it was an infinitely worse p=0.531. Instead of finding some reason for hope, the data indicated Axovant had even more reason to doubt success. And instead of going to the FDA looking for guidance on next steps in investigating the drug for dementia with Lewy bodies (DLB) patients with motor deficits as well as patients with more severe baseline psychotic symptoms, they’ll be sticking with DLB.

Vivek Ramaswamy

This, in the biotech world, is what is technically called a world-class mess up. Except they don’t use the word mess.

Ramaswamy has been able to raise $2 billion from investors based on his claim that the can find assets on the shelves of biopharma companies and quickly hustle them to approvals. Today, the biotech exec — who had been straightforward in presenting the first key failure for Alzheimer’s — is keeping a low profile as the company tries to set the record straight on the numbers.

It’s not a good week for the company.


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