Mind Medicine Inc., a leading biotech company developing psychedelic-inspired therapies, announced the initiation of Phase 2a proof-of-concept (POC) trial of lysergic acid diethylamide (LSD) in adult patients with attention deficit hyperactivity disorder (ADHD). The first site has been activated and patient enrollment is expected to start imminently. 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.
“We are pleased to activate our first site and excited to initiate patient enrollment of our ADHD proof-of-concept trial,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “The study builds on the growing evidence demonstrating LSD has the potential to improve mood and selective cognitive processes. Further, low doses of LSD have been shown to be safe, well tolerated and have 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.”
Dr. Matthias Liechti, University Hospital Basel and co-primary investigator of the trial commented, “Psychedelics including LSD have shown beneficial and lasting effects on mood when given at single doses producing psychedelic effects. There is anecdotal evidence for possible benefits of low to very low doses of psychedelics given repeatedly. This is the first controlled study to validly evaluate therapeutic effects of very low doses of a psychedelic in patients.”
“We are very much looking forward to initiating our ADHD trial with repeated low doses of LSD, which will be conducted at two top European clinical therapeutic sites,” said Dr. Miri Halperin Wernli, Executive President of MindMed. “We have designed a robust, randomized clinical trial to replicate and extend the promising findings of previously conducted smaller, open-label trials. This trial will evaluate our therapeutic regimen in a rigorously controlled setting and will help optimize the dosing schedule, compound selection and clinical management. Further, this trial will provide additional insight into the mechanisms by which psychedelics exert their therapeutic effects.”