MindMed Announces Initiation of Phase 1 Clinical Trial of Intravenous DMT

MindMed (NASDAQ: MNMD) (NEO: MMED), a leading biotech company developing psychedelic-inspired therapies, is pleased to announce the start of a Phase 1 clinical trial to assess the safety, pharmacokinetics and pharmacodynamics of DMT, a naturally occurring psychedelic substance and an active ingredient in ayahuasca. The outcome of this Phase 1 clinical trial is expected to facilitate potential future Phase 2 clinical trials of DMT in patients. The clinical trial is being conducted as an investigator-initiated study by Dr. Matthias Liechti as part of MindMed’s ongoing collaboration with the UHB Liechti Lab. The Phase 1 clinical trial has received all necessary regulatory approvals in Switzerland and subject enrollment has been initiated.

MindMed is exploring DMT as a potential drug candidate given its potential advantages as a short-acting psychedelic. MindMed plans to study an intravenous administration method [during its Phase 1 clinical trial] that would induce a stable and prolonged DMT experience. The intravenous administration method may also allow greater control of the patient experience by enabling an acute termination of the psychoactive effects of DMT. DMT administration has a rapid onset and offset compared to the longer-acting psychedelic substances like psilocybin and LSD.

We are very excited to start this study with Professor Matthias Liechti and University Hospital Basel. Currently no study has validly determined the elimination half-life of DMT or other pharmacokinetic parameters and our study will provide valuable information for future research on DMT as a tool to examine alterations of the mind. MindMed is exploring a number of psychedelic compounds as part of our mission to discover, develop and deploy psychedelic-inspired medicines and therapies to address mental illness and addiction. Our data driven approach drives our strategic choices for the development of both classical psychedelics and the very promising next generation novel chemical entities.

Dr. Miri Halperin Wernli, Executive President of MindMed

The goal of the clinical trial is to assess the safety, tolerability and dose-response of DMT, including an assessment of the difference between infusion conditions. The Phase 1 clinical trial will include 30 healthy subjects in a randomized 5-period crossover, double-blind, placebo-controlled design.

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