Vivek Ramaswamy’s Axovant has egg on its face after it was forced to own up to the fact it misreported mid-stage data on a drug it hoped to take into Phase III.
Vivek Ramaswamy’s Axovant has egg on its face after it was forced to own up to the fact it misreported mid-stage data on a drug it hoped to take into Phase III. Today, Axovant said the p-value data for its investigational drug nelotanserin was actually much worse than reported.
On Monday, Axovant, helmed by Chief Executive Officer David Hung, reported that nelotanserin, a 5-HT2a receptor inverse agonist, showed positive trend in motor improvement in patients with dementia with Lewy bodies (DLB) and Parkinson’s disease dementia (PDD). The data initially shared on the opening day of the J.P. Morgan Healthcare Conference, Axovant said the data for the Phase IIb trial showed that nelotanserin treatment at 40 mg for two weeks followed by 80 mg for two weeks resulted in a 1.21 point improvement (p=0.011, unadjusted). That was incorrect though. This morning, the company said the p-value was actually 0.531, unadjusted – meaning it was worse than previously reported.
Axovant had hopes of taking this trial to the next level. Now it will have to meet with the U.S. Food and Drug Administration to discuss a “larger confirmatory nelotanserin study” focused on patients with DLB with motor function deficits. Axovant said it may evaluate nelotanserin for psychotic symptoms in DLB and Parkinson’s disease dementia (PDD) patients in future clinical studies.
That embarrassing correction came on top of Axovant announcing that it was scrapping its lead product interperdine following a failure to meet primary endpoints in a Phase IIb trial. Axovant was developing interperdine, a 5-HT6 receptor antagonist the company acquired from GlaxoSmithKline, as a treatment for patients with dementia with Lewy bodies (DLB).
Following the announced decision to terminate the interperdine trial, share prices plunged by nearly 50 percent. Investors quickly dumped Axovant stock and caused prices to fall from $5.37 per share to $2.31.
Ramaswamy snagged interperdine from GSK for about $5 million after that company scrapped development. He believed there was value in the cast-off drug, but the company’s decision to scrap its own interperdine program shows that GSK made the right move. Writing in Endpoints News this morning, John Carroll noted that Ramaswamy has raised more than $2 billion on his claims that he can find gold in cast-off drugs. However, following the two announcements, Carroll said Ramaswamy is keeping a low profile at J.P. Morgan, one of the key biotech conferences of the year.
The failure of interperdine was another miss on developing a treatment for Alzheimer’s disease. A 5-HT6 receptor antagonist is believed to work as a treatment for Alzheimer’s and dementia by increasing the amount of acetylcholine in the brain. The drug was not expected to be a cure for Alzheimer’s but was believed by Axovant to have a chance to delay a worsening of symptoms. Axovant had hoped to succeed with the 5-HT6 receptor antagonist where others had not. Last year, Denmark-based H. Lundbeck A/S, scrapped its own 5-HT6 receptor antagonist program for Alzheimer’s. To say it’s been difficult to find a meaningful therapy for Alzheimer’s may be an understatement. BioSpace noted last year that well more than 125 Alzheimer’s drugs have failed in Phase III trials after promising results in early-stage trials.
