Mind Medicine Inc (NEO:MMED) (OTCQB:MMEDF) (FRA:MMQ), a psychedelic medicine biotech company, has completed a Phase 1 study on the acute dose-dependent effects of LSD in partnership with University Hospital Basel's Liechti Lab in Switzerland.
The completed study will help MindMed in dose-finding and the planning of future Phase 2 clinical trials of LSD in patients with anxiety disorders and other medical conditions, the company said.
The Phase 1 study measured subjective patient responses starting at microdoses (25 micrograms, or µg) up to experiential doses (200 µg). Maximal good drug effects were reached at a 100 µg dose.
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The 200 µg experimental dose LSD was shown to induce greater ego dissolution than a lesser 100 µg dose, the company said, which refers to losing one’s sense of self. Ego-dissolution is thought to be one of the key therapeutic potentials of the psychedelic experience and psychedelic-assisted therapy process.
MindMed's team is actively preparing what it is calling Project Lucy, which intends to evaluate the efficacy of LSD assisted therapy for anxiety disorders in a Phase 2b clinical trial.
"We see this now completed study as an important stepping stone with highly relevant data to support Project Lucy as the team identifies optimal dose levels of LSD to test in the intended Phase 2b trial of an anxiety disorder,” CEO J.R. Rahn said in a statement. “As COVID-19 continues to compound society's prevalence of anxiety disorders globally, MindMed is pushing ahead with full vigor on the planning and design of Project Lucy."
MindMed and University Hospital Basel are actively filing patent applications on clinical trial data generated through the collaboration's clinical trials and R&D. MindMed maintains an exclusive license to the data and IP generated through the research collaboration and licensing agreement between the parties.
The Phase 1 study used a double-blind, randomized, placebo-controlled, crossover design in 16 healthy participants (eight women, eight men) who underwent six 25-hour trial sessions where they received a placebo and the five varying doses of LSD.
In addition, effects of the high 200 µg dose of LSD were effectively prevented by a pre-treatment with the 5-HT2A receptor antagonist ketanserin, the company said, indicating that the psychedelic effects of LSD are primarily mediated by serotonin 5-HT2A receptor activation.
The study was published in Neuropsychopharmacology, an international scientific journal and the official publication of the American College of Neuropsychopharmacology (ACNP).
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