Phase 1 Study Measuring Dosing Effects of LSD Completed: Results of Study Will Aid In Planning a Phase 2 Study

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The study was published in Neuropsychopharmacology, which is an international scientific journal and the official publication of the American College of Neuropsychopharmacology (ACNP) and can be found here.

The completed Phase 1 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.

Specifically, the Phase 1 study measured LSD dose-dependently induced subjective responses starting at microdoses (25 ug) up to experiential doses (200 ug). Maximal good drug effects were reached at a 100 ug dose. However, an experiential dose of 200 ug LSD was shown to induce greater ego dissolution than a lesser 100 ug dose. 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 Project Lucy which intends to evaluate the efficacy of LSD assisted therapy for anxiety disorders in a Phase 2b clinical trial.

MindMed’s Co-Founder and Co-CEO, J.R. Rahn, commented on the results, “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. 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 numerous clinical trials and R&D. MindMed maintains an exclusive license to the data and IP generated through its continued research collaboration and licensing agreement with the Liechti Lab at University Hospital Basel.

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 h trial sessions and received placebo, LSD (25, 50, 100, and 200 µg), and 200 µg LSD 1 h after administration of ketanserin (40 mg). LSD showed dose-proportional pharmacokinetics and first-order elimination.

In addition, the effects of the high 200 µg dose of LSD were effectively prevented by pretreatment with the 5-HT2A receptor antagonist ketanserin indicating that psychedelic effects of LSD are primarily mediated by serotonin 5-HT2A receptor activation.

 

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