By Kamal Choudhury and Puyaan Singh
Sept 14 (Reuters) – 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.
Shares rose 5% on the news.
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.
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.
“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.
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.
(Reporting by Puyaan Singh and Kamal Choudhury in Bengaluru; Editing by Sahal Muhammed)
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