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

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

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A single 100-microgramme 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.

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 US 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.

"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 US 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 US, and if half of those treated two DT120 patients each month, annual treatment volume would be around 100,000 patients.

The 245 patients in ⁠the new trial ​received either 100 micrograms of DT120, a lower ​50-microgram dose or placebo.

Higher efficacy on the 100-microgram dose versus the 50-microgram one "gives us obviously an easier discussion (with ​regulators)," Barrow said.