Axovant scraps dementia drug development after negative results

The 5-ht6 antagonist failed to meet its primary efficacy endpoints in the phase 2b HEADWAY and pilot phase 2 Gait and Balance studies.

In the HEADWAY trial, intepirdine at both 35mg and 70mg, after 24 weeks of treatment, could not produce statistically significant improvements in patients with dementia with Lewy bodies (DLB) when compared with placebo-treated patients.

In the Gait and Balance studies, intepirdine at 35mg could not show any improvement in gait speed in patients with dementia and gait impairment.

Axovant Sciences CEO David Hung said: “Based on the totality of intepirdine data to date, there is no evidence to support its further development.

“We are incredibly disappointed and saddened for the millions of people living with these difficult conditions, and are deeply grateful to the patients, caregivers and investigators who participated in our trials.”

Intepirdine was designed to promote the release of the acetylcholine neurotransmitter in the brain, which is considered to be necessary in maintaining a person’s alertness, memory, thought and judgment.

In September 2017, Axovant reported that the drug failed to meet its co-primary efficacy endpoints in the phase 3 MINDSET trial in patients with mild to moderate Alzheimer's disease, who were on donepezil therapy over 24 weeks.

Axovant had a consolation though with its investigational drug nelotanserin meeting its primary endpoint of safety in a pilot phase 2 trial, dubbed Visual Hallucination. The study was held in patients with DLB and Parkinson’s disease dementia (PDD), who were troubled visual hallucinations.

Axovant stated that it will complete the HEADWAY and MINDSET extension studies appropriately by work alongside investigators.

Image: Intepirdine could not meet primary efficacy endpoints in HEADWAY, and Gait and Balance studies. Photo: courtesy of jk1991/FreeDigitalPhotos.net.