About Intepirdine (RVT-101)

Intepirdine (RVT-101) is an investigational drug candidate that has the potential to be a best-in-class, once-daily, orally-administered neurotransmitter-targeted therapy to improve cognition and daily functioning in people living with dementia. Intepirdine has a number of favorable properties as a product candidate for dementia.

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Favorable safety and tolerability profile observed with more than 1,300 human subjects exposed to intepirdine

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Immediate and sustained efficacy observed for at least 48 weeks over placebo in the Phase 2b clinical trial for intepirdine

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If approved, intepirdine will offer patients oral, once-daily dosing, without the need for PET imaging, MRI monitoring or IV infusions

 

Intepirdine (RVT-101) Clinical Trials

 

Intepirdine (RVT-101) is currently undergoing a Phase 3 international, multi-center, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and efficacy of intepirdine in patients with mild-to-moderate Alzheimer’s disease called the MINDSET study. If this study is successful, it could lead to the approval of intepirdine in the US and the EU for patients with mild-to-moderate Alzheimer’s disease.

Intepirdine is also currently undergoing a Phase 2b multi-center, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of intepirdine in patients with dementia with Lewy bodies called the HEADWAY-DLB study.

Intepirdine is also currently undergoing a Phase 2, multi-center, double-blind, placebo-controlled crossover study evaluating its effect on gait and balance in patients with dementia. In this study, Axovant intends to further investigate the observation of a reduced rate of falls seen in patients treated with intepirdine in the prior 684-patient study of intepirdine on a background of stable donepezil therapy

Intepirdine (RVT-101) is an investigational new drug candidate and is not approved for any indication in any markets.