Axovant Sciences says that the Phase III MINDSET clinical trial of its investigational drug intepirdine in patients with mild to moderate Alzheimer's disease (AD) who were receiving background donepezil therapy did not meet its co-primary efficacy endpoints.
The HEADWAY trial studying intepirdine in patients with dementia with Lewy bodies (DLB) remains on track to report top-line results at the end of 2017. This study investigates two doses of intepirdine, 35mg (the dose used in the MINDSET trial) and 70mg, a higher dose intended to engage both 5-HT6 and 5-HT2A receptors. Intepirdine has received Fast Track designation from the US Food and Drug Administration for the treatment of DLB.
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