MindMed Begins Phase 2 Clinical Trial of LSD for Treating "Suicide Headaches"

MindMed Is Collaborating on a Phase 2 Clinical Trial of LSD For Cluster Headaches with University Hospital Basel's Liechti Lab


BASEL, Switzerland, June 8, 2020 /PRNewswire/ -- Mind Medicine (MindMed) Inc. (NEO: MMEDOTCQB: MMEDF), is supporting and collaborating on a Phase 2 clinical trial evaluating LSD 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.

MindMed is the leading neuro-pharmaceutical company for psychedelic inspired medicines and previously formed an ongoing R&D 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 (3 x 100 µg 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 cross-over study design.

MindMed Co-founder & Co-CEO JR 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."

MindMed's collaboration will assess if there is clinical evidence for a future commercial drug trial through the FDA 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 MindMed 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, MindMed gains exclusive, global use to all data and IP generated in the Phase 2 trial of LSD for cluster headaches.

About MindMed
Mind Medicine (MindMed) Inc. is a neuro-pharmaceutical 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, is pursuing experiential psychedelic assisted therapy for the treatment of anxiety, and is collaborating on a clinical trial to evaluate LSD for the treatment of cluster headaches. The MindMed executive team brings extensive biopharmaceutical industry experience to this groundbreaking approach to the development of next-generation psychedelic medicines. MindMed trades on the NEO Exchange under the symbol MMED. MindMed can also be traded in the US under the symbol OTC: MMEDF and in Germany under the symbol DE:BGHM.

For more information: www.mindmed.co.

Cautionary Statements and Disclaimer:
This news release contains "forward-looking information" and "forward-looking statements" within the meanings of applicable securities laws, which may include, but is not limited to, statements with respect to anticipated business plans or strategies of MindMed, the anticipated date of completion of micro-dosing studies, the timing of any drug trials, the success of its clinical trials and the ability to enter into acquisitions or collaborations to enhance its drug development platform and IP portfolio.  Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of MindMed to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements contained herein are made as of the date of this press release and MindMed disclaims, other than as required by law, any obligation to update any forward-looking statements whether as a result of new information, results, future events, circumstances, or if management's estimates or opinions should change, or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements.

For further information:

Media Contact: Anna Walsh, E: mindmedpr@pacepublicrelations.com, P: 212-254-4730; or Investor Relations: invest@mindmed.co, https://www.mindmed.co
SOURCE Mind Medicine (MindMed) Inc.
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