Intepirdine Does Not Demonstrate Significant Improvement for Alzheimer Disease
Compared to placebo, patients treated with intepirdine experienced a non-significant improvement in cognition.
Axovant Sciences announced that their investigational treatment for Alzheimer disease, intepirdine, did not meet its co-primary efficacy endpoints in the Phase 3 MINDSET trial.
The study included patients with mild to moderate Alzheimer disease on donepezil therapy (n =1315) and compared once-daily oral doses of intepirdine 35mg to placebo over 24 weeks. The co-primary endpoints included changes from baseline in the Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL).
Compared to placebo, patients treated with intepirdine experienced a non-significant improvement in cognition (0.36 ADAS-Cog points; P =.22) and essentially no change in measures of activities of daily living (0.09 ADCS-ADL points; P =.83).
"While we are deeply disappointed by these trial results, we also are saddened for the millions of patients and families impacted by Alzheimer disease. However, we believe that the fight against Alzheimer and other important areas of unmet need in neurology is too important to be derailed by this setback," said David Hung, MD, chief executive officer of Axovant.
Intepirdine, a potent 5-HT6 receptor antagonist, is also being investigated in the HEADWAY trial in patients with Lewy body dementia; results from this study are expected at the end of 2017.
Axovant announces negative topline results of intepirdine phase 3 mindset trial in Alzheimer's disease [press release]. Basel, Switzerland: Axovant newsroom; September 26, 2017.