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Definium Says LSD-Based Pill Reduces Anxiety in Late-Stage Study
The company said the treatment produced a 5.4-point placebo-adjusted improvement on a standard anxiety scale and was generally well tolerated.
Definium Therapeutics announced on Wednesday that its Phase 3 'Voyage' study of the LSD-based experimental pill DT120 met its primary goal, significantly reducing anxiety symptoms in adults with generalized anxiety disorder.
Generalized anxiety disorder affects approximately 26 million U.S. adults, yet the last new FDA-approved treatment for the condition occurred nearly two decades ago, creating significant unmet clinical need.
The 214-patient trial showed participants receiving the 100-microgram DT120 dose experienced an 11.6-point reduction on the Hamilton Anxiety Rating Scale at week 12, compared to a 6.2-point drop for the placebo group.
Following the announcement, shareholders pushed the company's stock up 15% to just over $47 apiece at market open Wednesday, though the share price settled around $43 by mid-morning.
Definium expects a second Phase 3 trial called 'Panorama' to produce data in September; Evercore ISI analyst Gavin Clark-Gartner models $2 billion in peak annual sales for DT120 in generalized anxiety disorder.