Otsuka Drops Alzheimer’s Agitation Drug Following Phase III Failure

2024-05-22

临床3期并购临床结果上市批准临床2期

Pictured: Husband consoles agitated wife/iStock, Piksel Otsuka Pharmaceuticals announced Wednesday it is terminating development of its Alzheimer’s-related agitation drug candidate following a failed late-stage trial. Top-line Phase III results in February revealed AVP-786 did not provide improvement over placebo in patients’ Cohen-Mansfield Agitation Inventory (CMAI) total score in treating agitation associated with dementia due to Alzheimer’s disease (AD). The asset was acquired by Otsuka in late 2014 in a $3.5 billion acquisition of Avanir Pharmaceuticals. The combination formula of ultra-low dose quinidine plus deuterium-modified dextromethorphan was expected to boost bioavailability and be less susceptible to metabolism. Previously tested by Avanir in major depressive disorder, Otsuka Otsuka was assessing AVP-786 only in AD agitation. The Japanese pharma already has a drug on the market for the indication with partner Lundbeck. Rexulti (brexpiprazole) was first approved in schizophrenia and as an adjunctive therapy for MDD. In May 2023, it became the first drug approved for agitation associated with dementia from AD. The additional indication is driving growth of the drug sales for the partners, with 18.8% monthly demand growth, Lundbeck reported. However, the competitive landscape in AD agitation is heating up. In April 2024, IGC Pharma announced interim data from its Phase II trial in the indication. The Maryland-based company is the first to trial a THC-based formulation in AD and showed significant reduction in agitation at week two compared to placebo. Axsome Therapeutics’ Phase III trial of twice-daily AXS-05 is slated to be completed in the first half of 2024. The company plans to apply for approval after the trial, following prior FDA feedback for long-term safety data. An estimated 6.9 million Americans suffer from AD with around 76% experiencing from agitation. Symptoms include pacing, restlessness, and verbal and physical aggression, adding significant burden to caregivers. Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.

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