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Axovant Neuro Drug Stumbles and Falls in Phase 2, Shares Drop 50%

Xconomy National — 

A drug intended to treat a form of dementia has failed in a pair of mid-stage clinical studies, and the company that developed it, Axovant, now says it will stop work on the compound altogether.

Axovant (NASDAQ: AXON) was testing its drug intepirdine as a treatment for dementia with Lewy bodies (DLB), a progressive brain disorder characterized by the abnormal buildup of a protein called alpha-synuclein, also called Lewy bodies. Patients who have DLB experience problems with thinking, memory, movement, and sleep, and can also show behavioral changes, according to the Lewy Body Dementia Association.

On Monday, Basel, Switzerland-based Axovant said intepirdine failed to beat a placebo in two separate Phase 2 studies. The results come a little more than three months after the company reported that the same drug failed in an Alzheimer’s disease clinical trial. Shares of Axovant lost more than half their value, falling to $2.53 apiece following the release of the latest clinical trial results.

The Axovant DLB study, called HEADWAY, was designed to test intepirdine’s ability to improve motor function. The 24-week study enrolled 269 patients and tested high and low doses of the Axovant drug. The company said that patients given intepirdine scored worse on a motor function measures compared to those given a placebo. Patients on the Axovant drug also scored worse on a scale used to evaluate cognition. The only measure where the Axovant drug beat a placebo was an evaluation of social, psychological, and occupational function in patients.

The other Phase 2 study focused on gait and balance. The study tested the low dose of intepirdine in 38 patients who have Alzheimer’s, Parkinson’s, or DLB. Axovant says its drug failed the study’s main goal of improving gait speed after two weeks of treatment.

Axovant is a subsidiary of Roivant Sciences, a company founded by hedge fund manager Vivek Ramaswamy. Ramaswamy’s approach to drug development is to find compounds that big pharma companies have stopped working on, acquire the rights to them, and them support them with cash and other resources to bring them through clinical testing. Roivant has operations in New York, San Francisco, Cambridge, MA, Durham, NC, and Switzerland. Roivant formed Axovant after acquiring intepirdine for $5 million, despite the drug’s spotty track record, from GlaxoSmithKline (NYSE: GSK) in 2014.

In a prepared statement, Axovant CEO David Hung said that the data from the intepirdine clinical trials provides no evidence to continue work on the drug. Separately, Axovant reported encouraging results from a pilot study for nelotanserin, a drug developed to treat visual hallucinations in DLB and Parkinson’s disease patients. Hung said the company plans to discuss with the FDA plans for a larger study that could confirm the pilot study’s results.

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