Axovant Sciences has reported negative top-line results from its Phase III MINDSET clinical trial of intepirdine conducted to treat mild-to-moderate Alzheimer’s disease (AD).
Intepirdine is an investigational, oral, once-daily 5-HT6 receptor antagonist being developed to release acetylcholine required for cognition and function in the brain.
The trial did not meet its co-primary efficacy endpoints and the results revealed that patients administered with 35mg of intepirdine did not achieve improved cognition at 24 weeks, compared to placebo.
Additionally, patients did not experience improvement in measures of daily activities analysed using Alzheimer’s disease assessment scale-cognitive subscale (ADAS-Cog) and Alzheimer’s disease cooperative study activities of daily living scale (ADCS-ADL).
The global, randomised, double-blind, placebo-controlled MINDSET trial assessed the safety, efficacy and tolerability of intepirdine in 1,315 patients who were on background donepezil therapy.
Axovant CEO David Hung said: “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.”
In the Phase III trial, intepirdine was observed to be generally well tolerated and achieved significant improvement in only one key secondary endpoint; the clinician interview-based impression of change.
The firm intends to continue evaluation of intepirdine in the Phase IIb HEADWAY trial being performed in dementia patients with Lewy bodies (DLB).
Expected to report top-line data by the end of this year, the Phase IIb trial is investigating 35mg of intepirdine, along with its 70mg dose to target both 5-HT6 and 5-HT2A receptors.