Axovant Sciences Ltd (NASDAQ:AXON) reported that the Phase III MINDSET clinical study of its investigational medication intepirdine in patients with mild to moderate AD who were getting background donepezil therapy failed to meet its co-primary efficacy objectives.
At 24 weeks, patients cured with 35 mg of intepirdine didn’t witness improvement in cognition or in measures of activities of everyday living as computed by the ADAS-Cog and by the ADCS-ADL, respectively, compared to people cured with placebo. In the trial, intepirdine was well tolerated.
The details
Axovant Sciences will work with investigators to complete the MINDSET open-label extension trial. David Hung, M.D., the CEO, expressed that while they are extremely disappointed by these study data, they also are saddened for the numerous patients and their families affected by Alzheimer’s disease. However, they consider that the combat against Alzheimer’s and other vital areas of unmet need in neurology is too vital to be derailed by this obstacle.
They are grateful to the patients, caregivers and investigators who participated in this vital trial and supported them in this journey. In addition, they remain dedicated to developing their pipeline, which comprises their Phase 2b HEADWAY trial of intepirdine, and nelotanserin, their highly selective inverse agonist of the ‘5-HT2A’ receptor in Phase II advancement, both of which are being assessed in people with dementia with Lewy bodies.
The HEADWAY study assessing intepirdine in people with dementia with Lewy bodies remains on track to post topline data at the close of 2017. This study analyzes two doses of intepirdine, 70 mg, a higher dose planned to engage 5-HT6 as well as 5-HT2A receptors, and 35 mg – the dose administered in the MINDSET trial. Intepirdine has obtained Fast Track status from the U.S. Food and Drug Administration for the cure of dementia with Lewy bodies. As it is known, Alzheimer’s disease is the most prevalent form of dementia.
