Axovant Sciences, a clinical-stage biopharmaceutical company, has revealed negative topline results of its Phase III MINDSET trial in Alzheimer’s disease, but the CEO has stressed that the company will continue advancing its pipeline in neurological therapies.
Alzheimer's
“While we are deeply disappointed by these trial results, we also are saddened for the millions of patients and families impacted by Alzheimer's disease. However, we believe that the fight against Alzheimer's and other important areas of unmet need in neurology is too important to be derailed by this setback,” said Dr David Hung, chief executive officer of Axovant.
The MINDSET trial was a global, randomised, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy, safety and tolerability of Axovant’s investigational drug intepirdine in patients with mild to moderate Alzheimer’s disease on donepezil therapy over 24 weeks. At 24-weeks patients in the treatment arm of the study were not found to have improved cognition or measures of activities of daily living in comparison to those who were treated with placebo.
“We are grateful to the investigators, patients and caregivers who participated in this important trial and supported us in this journey,” continued Hung. “Moreover, we remain committed to advancing our pipeline, which includes our Phase IIb HEADWAY study of intepirdine and nelotanserin, our highly selective inverse agonist of the 5-HT2A receptor in Phase II development, both of which are being evaluated in patients with dementia with Lewy bodies.”
The company’s HEADWAY trial, studying intepirdine in patients with dementia with Lewy bodies (DLB), remains on track to report topline results at the end of the year. This study investigates two doses of intepirdine, 35 mg (the dose used in the MINDSET trial) and 70 mg, 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.