Definium's LSD-based anxiety, depression drug scores another trial win

Regulatory and investor enthusiasm for psychedelic-based therapies has helped Definium shares nearly triple this year.

DT120 had significantly reduced anxiety symptoms in the first trial for GAD, Definium said in August. CEO Robert Barrow said ahead of Monday's results that having two studies answers "questions around the attribution of what's driving drug effect," as the company plans to file for the U.S. FDA's approval in the first half of next year.

The drug was also successful in treating depression in another late-stage study, Definium had said in June. The company is pursuing a broad label to treat both GAD and depression with no fixed dosing intervals.

Definium Therapeutics said on Monday its LSD-based treatment reduced symptoms of generalized anxiety disorder in a second successful late-stage study for the condition.

A single 100-microgram dose of DT120, a fast-dissolving tablet of lysergide, or LSD, reduced scores on an anxiety scale by 9.8 points after 12 weeks, compared with a 4.7-point decline for placebo, the company said.

Shares rose 5% on the news.

"It is really fascinating to see 3 back-to-back trials that show shockingly consistent benefits – this is just not something you normally see in the neuropsych field," said Evercore ISI analyst Gavin Clark-Gartner.

GAD affects about 26 million U.S. adults and is commonly treated using antidepressants, anti-anxiety medicines and psychotherapy. No new treatments have been approved for nearly two decades.

Barrow said that about 8,000 interventional psychiatry sites operate in the U.S., and if half of those treated two DT120 patients each month, annual treatment volume would be around 100,000 patients.