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ARTICLE | Product Development

Axsome speeds Alzheimer's agitation trial, citing patient vulnerability and FDA guidance

March 20, 2020 2:48 PM UTC
Updated on Mar 20, 2020 at 9:05 PM UTC

While some biotechs are delaying or pausing clinical studies during the COVID-19 crisis, Axsome is hurrying one trial along to an early finish -- and citing FDA guidance issued this week as part of its rationale.

Axsome Therapeutics Inc. (NASDAQ:AXSM) said Friday it has concluded enrollment and is winding down subjects' participation in the 435-patient Phase II/III ADVANCE-1 trial of AXS-05, its multimodal NMDA receptor antagonist to treat Alzheimer's disease agitation. Citing the vulnerability of the trial's over-65 population, Axsome said it made the decision to ensure patient safety, and said the trial's early end will allow its participants to comply with directives that they isolate at home...

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Axsome Therapeutics Inc.