Axovant Abandons Alzheimer’s Drug Candidate After Clinical Trial Failure

Yesterday, biopharmaceutical company Axovant announced it would cease development of its lead neuroscience candidate, intepirdine, after a Phase IIb clinical trial in Lewy body dementia came back with negative results. The 5-HT6 inhibitor previously failed to show any benefit in patients with mild-to-moderate Alzheimer’s disease in the company’s MINDSET trial.

Axovant was working with Roivant Sciences in the hopes of eventually commercializing intepirdine. The drug candidate was also tested for efficacy in improving gait and balance in dementia patients, however studies were unsuccessful.

“Based on the totality of intepirdine data to date, there is no evidence to support its further development,” said Dr. David Hung, chief executive officer of Axovant. “Separately, we will be working with Roivant to build our pipeline to develop other new therapies for patients with neurological conditions who so desperately need them.”

Originally licensed from GlaxoSmithKline in 2014, intepirdine was largely investigated as an add-on drug to boost the effectiveness of cholinesterase inhibitors and other Alzheimer’s therapies. The failure comes as large drugmakers like Pfizer are shutting down their neuroscience R&D divisions in light of their own struggles in developing effective disease-modifying therapies for Alzheimer’s and other neurological diseases.

Axovant will now focus on developing another Lewy body dementia drug candidate, nelotanserin, which has shown promising results in early phase clinical trials. The drug is a 5-HT2a receptor inverse agonist and is being assessed as a possible treatment for Lewy body dementia-associated sleep disorders and visual hallucinations.

In addition, nelotanserin is also being tested in Parkinson’s disease dementia, a condition linked to the accumulation of Lewy bodies in the brain. Patients given nelotanserin in trials of the drug have shown improvement on the Unified Parkinson’s Disease Rating Scale (UPDRS) part III, with possible effects on hallucinations.