Vivek Ramaswamy’s first big bet on bringing a drug back from Big Pharma’s discard list is a complete bust. And another setback in the pipeline has conspired to scuttle its stock price this morning.
The biotech financier’s Axovant, floated in an IPO that funded an expensive quest to put intepirdine back into the clinic for neuro conditions, reported out this morning that both doses of the therapy tested for dementia with Lewy bodies failed to significantly improve symptoms for patients. The drug has also failed spectacularly for Alzheimer’s, leaving Ramaswamy’s operation at Roivant with no choice but to kill the program.
The data actually highlighted a worsening in disease scores for two measures used to evaluate the low dose in the study while the top dose consistently fell short of the mark.
Investors bailed on the news, sending the stock down 49% in pre-market trading.
Said Axovant CEO David Hung in a statement:
“Based on the totality of intepirdine data to date, there is no evidence to support its further development.”
Ramaswamy was able to in-license the failed Alzheimer’s drug from GSK for only $5 million. But he sold it to investors in a record-setting IPO back in 2015, hauling in $315 million during a big bull market for biotech. Since then he’s gathered about $2 billion together for a set of startups that have been busily scooping up drugs off of biopharma’s shelves. But every miss in the clinic will raise new questions about the value of his strategy.
Ramaswamy badly needs a win.
In an effort to try and take some of the sting out of the lead failure, Axovant spotlighted some hopeful signs seen in a post hoc analysis on a separate study of nelotanserin. But that drug also failed the key efficacy endpoint for dementia patients with visual hallucinations.
In a prespecified ITT analysis, nelotanserin treatment versus placebo (n=27) resulted in a 3.12 point improvement in the (Unified Parkinson’s Disease Rating Scale) Part III with a positive trend (p=0.075, unadjusted). Notably, in a prespecified analysis of the DLB patient subset (n=19), nelotanserin improved the UPDRS Part III by 4.00 points (p=0.041, unadjusted).
About a year ago Axovant touted positive signs from the first stage of the study, but also conceded a key miss on the secondaries, failing to improve the frequency of visual hallucinations. Nevertheless, the company headed straight into Phase III to underscore Ramaswamy’s commitment to rapid-fire clinical testing.
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