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MindMed phase 2 LSD trial starts taking patients

2020-06-08 08:09 ET - News Release

Mr. J.R. Rahn reports


Mind Medicine (MindMed) Inc. is supporting and collaborating on a phase 2 clinical trial evaluating LSD (lysergic acid diethylamide) for the treatment of cluster headaches at University Hospital Basel's Liechti Lab. The Phase 2 trial began recruiting patients in early January and has commenced treating patients with LSD.

Mind Medicine is the leading neuropharmaceutical company for psychedelic inspired medicines and previously formed a continuing research and development collaboration with the University Hospital Basel's Liechti Lab, the leading global clinical research laboratory for LSD, to evaluate multiple therapeutic uses of psychedelics and next-gen psychedelic therapies. This new development is part of the collaboration and Dr. Matthias Liechti is serving as principal investigator of the clinical trial.

Cluster headaches, also known as suicide headaches due to the severity of the pain caused, are often viewed as one of the most profoundly painful conditions known to mankind. The pain occurs on one side of the head or above an eye and can last for weeks or months. Studies have demonstrated increased suicidality associated with patients experiencing cluster headache attacks.

Non-clinical and anecdotal evidence suggests LSD can abort attacks and decrease the frequency and intensity of the attacks. There is a need for new treatment approaches for cluster headaches as current available medications often mismanage cluster attack periods.

The phase 2 trial is investigating the effects of an oral LSD pulse regimen (three times 100-microgram LSD in three weeks) in 30 patients suffering from cluster headaches compared with placebo. The study is a double-blind, randomized, placebo-controlled two-phase crossover study design.

Mind Medicine co-founder and co-chief executive officer J.R. Rahn said: "As we continue on our mission to discover, develop and deploy psychedelic inspired medicines, we are very encouraged to bring this potential treatment for cluster headaches using LSD out of the shadows and evaluate its efficacy based on clinical research standards with the Liechti Lab."

Mind Medicine's collaboration will assess if there is clinical evidence for a future commercial drug trial through the Food and Drug Administration pathway at a later date. Treatments for cluster headaches may potentially qualify for an orphan drug designation and be eligible for certain development incentives provided by the FDA for rare diseases.

Liechti Lab and Mind Medicine intend to learn how they can make the administration of LSD more targeted for cluster headache patients through this phase 2 trial and future clinical trials. As part of the collaboration with UHB Liechti Lab, Mind Medicine gains exclusive, global use to all data and IP (intellectual property) generated in the phase 2 trial of LSD for cluster headaches.

About Mind Medicine (MindMed) Inc.

Mind Medicine (MindMed) is a neuropharmaceutical company that discovers, develops and deploys psychedelic inspired medicines to improve health, promote wellness and alleviate suffering. The company's immediate priority is to address the opioid crisis by developing a non-hallucinogenic version of the psychedelic ibogaine. In addition, the company has established a microdosing division to conduct clinical trials of LSD microdosing for adult ADHD.

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