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Axovant’s Alzheimer's drug intepirdine fails in phase 3 trial

PBR Staff Writer Published 27 September 2017

Axovant Sciences has reported that intepirdine, its 5-ht6 antagonist to treat Alzheimer's disease (AD), failed to meet its co-primary efficacy endpoints in a phase 3 trial.

The phase 3 clinical trial dubbed as MINDSET featured 1,315 patients with mild to moderate Alzheimer's disease who were on donepezil therapy over 24 weeks.

Intepirdine taken orally daily once in strength of 35mg was evaluated for its efficacy, safety and tolerability in comparison to placebo in patients aged between 50 and 85 years of age.

Axovant, a subsidiary of Roivant Sciences, said that its Alzheimer's drug compared to placebo, could not show any improvement in cognition or in measures of activities of daily living among the patients who were administered with it. However, it stated that the investigational drug was generally well tolerated at 24 weeks of the trial.

Axovant revealed that only the first key secondary endpoint of the trial could show any significant improvement in the intepirdine arm which was the Clinician Interview-Based Impression of Change plus caregiver interview (CIBIC+).

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.”

The company plans to continue with its HEADWAY trial which is evaluating intepirdine in patients with dementia with Lewy bodies (DLB). Results of the trial are expected to come out by the year end.

According to Axovant, Intepirdine promotes the release of the acetylcholine neurotransmitter in the brain which is believed to be essential in maintaining one’s alertness, memory, thought and judgment.


Image: AD drug intepirdine could not meet co-primary efficacy endpoints in a phase 3 trial. Photo: courtesy of jk1991 / FreeDigitalPhotos.net.