Definium's LSD-based anxiety drug succeeds in second late-stage trial
Definium Therapeutics said its LSD-based tablet DT120 reduced generalized anxiety disorder symptoms in a second late-stage study, lifting its shares nearly 20% premarket.
Definium Therapeutics reported that its LSD-based treatment reduced symptoms of generalized anxiety disorder (GAD) in a second successful late-stage trial, a result that sent its shares up nearly 20% in premarket trading on Monday.
According to the company, a single 100-microgram dose of DT120 — a fast-dissolving tablet form of lysergide, or LSD — lowered scores on an anxiety scale by 9.8 points after 12 weeks. Participants who received a placebo recorded a 4.7-point decline over the same period.
The new trial enrolled 245 patients, who were assigned to receive either 100 micrograms of DT120, a lower 50-microgram dose, or a placebo. The lower-dose arm was included to address functional unblinding, a common limitation in clinical trials in which participants can correctly guess whether they have been given the active drug because of distinctive side effects or unmistakable drug experiences.
Even with that design, patients at both dose levels were able to correctly identify when they had received the drug rather than the placebo, CEO Robert Barrow said. He noted that the stronger efficacy seen at the 100-microgram dose compared with the 50-microgram dose gives the company an easier discussion with regulators.
The result follows a first trial in which DT120 had also significantly reduced anxiety symptoms, the company said in August. Barrow said having two studies helps answer questions about what is driving the drug's effect, as Definium pursues approval from the U.S. Food and Drug Administration in the first half of next year.
He added that roughly a dozen programs have sought approval for GAD over the past 20 years without success.
GAD, marked by persistent and excessive worry that can interfere with daily life, affects about 26 million adults in the United States. It is commonly treated with antidepressants, anti-anxiety medicines and psychotherapy.
Psychedelic-based therapies have drawn growing regulatory and investor interest, helping Definium's shares nearly triple this year. Psychedelic drugs can temporarily alter perception, mood and thinking.