Axsome Therapeutics Drug Trial Shows Eased Agitation in Alzheimer's Patients

Axsome's treatment 'rapidly improved agitation symptoms,' the company says. About 70% of Alzheimer's patients experience agitation.
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Shares of Axsome Therapeutics  (AXSM) - Get Report rocketed higher Monday after the biotechnology company announced that its experimental Alzheimer’s medication reduced agitation in a trial of Alzheimer’s patients.

“AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the primary endpoint in the ADVANCE-1 Phase 2/3 trial and rapidly, substantially, and significantly improved agitation in patients with Alzheimer’s disease as compared to placebo,” the company said in a statement.

A total of 366 Alzheimer’s patients were treated in the study. AXS-05 has been granted Food and Drug Administration Fast Track designation for the treatment of Alzheimer’s disease agitation, the company said Monday.

No FDA-approved treatments for Alzheimer’s disease agitation currently exists. Alzheimer’s represents the most common form of dementia and includes behavioral symptoms such as agitation. About 70% of Alzheimer’s patients suffer agitation.

“AXS-05 rapidly improved agitation symptoms,” the company said. “Improvement on the Cohen Mansfield Agitation Inventory total score with AXS-05 was numerically superior to placebo starting at Week 2.”

Axsome Therapeutics officials, of course, were pleased with the results. “The positive ADVANCE-1 Phase 2/3 trial represents a potentially important milestone,” Axsome Therapeutics CEO Herriot Tabuteau said in a statement.

“We look forward to discussing these data with the FDA. These results underscore the potentially broad applicability of the pharmacology of AXS-05, which has also resulted in positive pivotal trial results in major depressive disorder,” the CEO added.

At last check, Axsome Therapeutics shares traded at $95.27, up 24.70%. The stock has gained 12% over the last three months.