Neuro-pharmaceutical and psychedelics company Mind Medicine Inc. MNMD MMED MMQ announced Friday the initiation of Phase 2a proof-of-concept trial of LSD (lysergic acid diethylamide) in adult patients with attention deficit hyperactivity disorder.
The company said it expects to start patient enrollment soon, considering that the first site has been activated.
Dr. Matthias Liechti, University Hospital Basel and co-primary investigator of the trial, said that this is the first "controlled study to validly evaluate therapeutic effects of very low doses of a psychedelic in patients."
The POC trial will be conducted in collaboration with the University Hospital Basel in Switzerland and Maastricht University in the Netherlands and is designed to evaluate the therapeutic utility of repeated low doses of LSD.
The trial plans to enroll a total of 52 patients that will receive 20µg of LSD every dose schedule or placebo for six weeks. The primary endpoints are a mean change from baseline in ADHD symptoms.
MindMed acquired exclusive rights to data, compounds and patents for research with LSD and other psychedelics from the Liechti laboratory in Switzerland's University Hospital Basel last year.
Robert Barrow, CEO and director of MindMed, explained that the study "builds on the growing evidence demonstrating LSD has the potential to improve mood and selective cognitive processes."
He emphasized that low doses of LSD have been proved safe and well-tolerated, having minimal effects on physiological parameters.
"In collaboration with our renowned clinical researchers and team of leading investigators, we look forward to driving this exploratory trial forward as part of our broader comprehensive LSD clinical development strategy," Barrow added.
Dr. Miri Halperin Wernli, executive president of MindMed, said that a trial with repeated low doses of LSD would be conducted at two Europe-based clinical therapeutic sites.
"This trial will evaluate our therapeutic regimen in a rigorously controlled setting and will help optimize the dosing schedule, compound selection, and clinical management," Wernli said.
More recent news from MindMed:
MindMed Names Robert Barrow As CEO & Director, Announces Management Shake-Ups
EXCLUSIVE: MindMed CEO Rob Barrow On Growth Aspirations, Development Pipeline
FDA Shows Support For Development Of MindMed's Session Monitoring System
MNMD Price Action
MindMed's shares traded 0.30% higher at $1.6599 per share at the time of writing on Friday.
Photo: Courtesy of Louis Reed on Unsplash
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