By Kamal Choudhury
Aug 12 (Reuters) – Definium Therapeutics’ LSD-based experimental pill exceeded investor expectations by significantly reducing anxiety symptoms in a late-stage study, meeting the trial’s main goal, the company said on Wednesday.
The 214-patient trial tested a single 100-microgram dose of DT120, a fast-dissolving tablet of lysergide, the chemical name for LSD, in adults with generalized anxiety disorder, or GAD, who on average had suffered symptoms for 24 years.
Patients on the drug had an 11.6-point drop on a standard anxiety rating scale at week 12, compared with a 6.2-point drop for those on a placebo.
The placebo-adjusted difference of 5.4 points was statistically significant and clinically meaningful, the company said.
RBC Capital Markets analyst Brian Abrahams said the data exceeded Wall Street’s expectations and the efficacy seen with other therapies for the disease, while Jefferies analysts described it as “one of the strongest” placebo-adjusted benefits ever seen in GAD.
Abrahams added the data cemented Definium’s position as a “leader in the emerging, transformative psychedelic mental health space.”
The benefit emerged as early as two days after dosing and lasted throughout the 12-week study.
The drug belongs to a class of compounds known as psychedelic medicines.
Regulatory and investor enthusiasm for psychedelics has helped Definium shares more than triple so far this year. The stock was up more than 6% in morning trading.
GAD, characterized by persistent and excessive worry that can interfere with daily life, affects about 26 million U.S. adults and is commonly treated with antidepressants, anti-anxiety medicines and psychotherapy.
No new drug has been approved for the condition in nearly two decades.
Unlike most anxiety medicines, which are typically taken regularly, DT120 is designed to be administered as a single dose during a monitored dosing session.
Most side effects were mild to moderate, with no increase in suicidal thoughts.
The trial marks Definium’s second late-stage success for DT120, with results from a second GAD study due in September, paving the way for a potential dual GAD and major depressive disorder regulatory filing.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Tasim Zahid and Devika Syamnath)
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