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Axovant Plans Nelotanserin PhIII But Trial Endpoint Has Eyebrows Raised

 
• By Lucie Ellis-Taitt

Axovant will move its 5HT2A receptor, nelotanserin, into Phase III studies later this year for Lewy body dementia patients, but the company is switching gears to focus on motor function over its previously stated target of visual hallucinations in patients.

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Axovant will take dementia drug into Phase III later this year • Source: Shutterstock

Swiss biopharma Axovant Sciences Ltd. reported on Feb. 13 positive interim Phase II data for the first 11 Lewy body dementia patients to complete its study for dementia drug nelotanserin – results that have prompted the company to take the drug into Phase III this year. But its plans to use the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III for a primary endpoint have piqued analysts' interest as the only other Phase III study to use this scale as endpoint in dementia failed last year.

The double-blind, randomized, placebo-controlled Phase II trial includes patients with either dementia with Lewy bodies or Parkinson's disease dementia (PDD) who experience frequent visual hallucinations with a score of 18 or higher on Mini Mental State Examination (MMSE). Previously, Axovant had said it would predominantly evaluate nelotanserin for the treatment of visual hallucinations in dementia patients

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