Axovant Sciences Ltd (NASDAQ:AXON) has announced that its pipeline treatment for Alzheimer’s disease has failed to provide positive results in its phase 3 clinical trials.
The company announced on Tuesday that its Alzheimer’s drug known as intepirdine failed to produce positive results in its phase 3 MINDSET trials. The clinical trials involved patients suffering from mild to moderate Alzheimer’s. The announcement revealed that the patients in the MINDSET clinical trials received background donepezil therapy but the pipeline treatment failed to achieve its co-primary efficacy endpoints. The patients were treated with 35 mg of intepirdine for 24 weeks but there were no cognitive improvements.
The clinical study involved both the Alzheimer’s Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL), and the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog). There were no significant improvements from baseline in cognition after the 24 weeks of treatment using Interpirdine compared to the placebo.
“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,” stated Axovant CEO, David Hung.
Hung further stated that the company was grateful to the patients, caregivers, and investigators for their participation throughout the entire period of the clinical study. He also added that Axovant is still committed to advancing its pipeline. This includes a phase 2b HEADWAY study of nelotanserin and intepirdine among others.
The HEADWAY study of Intepirdine is still expected to report positive results towards the end of the year, despite the unyielding nature of the MINDSET clinical trials of the same treatment. The study will determine the effect of two doses of intepirdine, 35 mg and a higher dose of 70 mg that is expected to engage the 5-HT6 as well as the 5-HT2A receptors. The pipeline treatment has also been awarded a Fast Track designation by the Food and Drug Administration (FDA) for use to treat patients suffering from dementia with Lewy bodies (DLB).
