2022-11-29| Trials & Approvals

Axsome’s AXS-05 Achieves Endpoints In Alzheimer’s Agitation Trial

by Joy Lin
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Axsome has announced that AXS-05, its experimental treatment for agitation in Alzheimer’s disease (AD), has reached primary and key secondary endpoints in a Phase 3 trial. 

Agitation occurs in up to 70% of patients with AD and is characterized by emotional distress, aggressive behaviors, impulsivity, and irritability. It is one of the most troubling aspects of AD for patients and caregivers as it is linked to early nursing home placement, accelerated cognitive decline, and increased mortality, said Jeffrey Cummings, MD, ScD, Director of the Cleveland Clinic Lou Ruvo Center for Brain Health.

In the Phase 3 trial called Accord, AXS-05 was shown to delay and prevent the relapse of agitation compared to the placebo. The trial win follows Roche’s gantenerumab flop in two much-awaited Phase 3 trials, which has cemented Biogen and Eisai’s lecanemab as a frontrunner in AD treatments. 

Related Article: Roche’s Gantenerumab Fails Trials In Alzheimer’s Disease

Delaying And Preventing Relapse In Agitation 

AXS-05, also called dextromethorphan-bupropion, is an oral N-methyl-D-aspartate (NMDA) receptor antagonist with multi-modal activity that is being investigated for the treatment of agitation in AD and other central nervous system (CNS) disorders.

The dextromethorphan component of AXS-05 is an uncompetitive NMDA receptor antagonist, also known as a glutamate receptor modulator, and a sigma-1 receptor agonist. The bupropion part of the drug increases the bioavailability of dextromethorphan and also acts as a norepinephrine and dopamine reuptake inhibitor.

In Accord, which enrolled 178 patients with AD showed that  AXS-05 treatment resulted in a 3.6-fold lower risk of relapse versus placebo. The drug also met the key secondary endpoint of relapse prevention, with 7.5% of AXS-05-treated patients relapsing compared to 25.9% of patients in the placebo arm. 

Treatment also improved symptoms of agitation, with clinicians and caregivers reporting improvement in over 86% of patients by Week 5 of treatment. Additionally, depressive symptoms and aggressive behavior were reported to be significantly reduced after AXS-05 treatment. 

The rates of adverse events observed during the trial were 28.3% in the AXS-05 group and 22.2% in the placebo group. The side effects did not lead to the discontinuation of AXS-05. 

Axsome has stated its intention to discuss with the FDA the new findings in Accord, which complements a previously completed trial called Advance-1. Results from Advance-1 contributed to AXS-05’s Breakthrough Therapy Designation by the FDA in June 2020. 

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