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Press Release

MindMed Announces the Start of the First-Ever Clinical Trial Combining MDMA and LSD

BASEL, SwitzerlandJan. 20, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company, announced today the start of the first ever clinical trial measuring and evaluating MDMA and LSD used in combination in the human body. The trial will be conducted at the University Hospital Basel Liechti Lab, in Basel, Switzerland.

If administered in combination with LSD, MDMA may increase positive subjective drug effects, including positive mood and empathy, and reduce the negative emotions and anxiety that are sometimes associated with LSD – producing an overall more positive experience.

MindMed is undertaking a Phase 1 clinical trial to evaluate if MDMA, when balanced and used in combination with LSD, can help offset some of the known potential unpleasant effects of LSD that occur in therapy or clinical settings. MindMed is interested in understanding how to balance both MDMA and LSD in a cohesive way to create better patient outcomes, and develop more advanced psychedelic assisted therapies, as MindMed expands both its R&D and commercial drug development pipeline. The study is anticipated to take around one year to complete.

President of MindMed, Dr. Miri Halperin Wernli added, “I believe that when LSD and MDMA are taken together they have exceptional potential to open a window into our mind which will awaken it to new levels of awareness by changing the fluidity of the ‌state‌ ‌of‌ ‌consciousness, amplifying‌ ‌changed‌ ‌perceptions,‌ ‌intensifying ‌emotions‌, ‌and‌ stimulating ‌novel‌ ‌thoughts. It is like a gateway to a multidimensional universe.‌”

The Phase 1 double-blind, placebo-controlled, 4-period crossover design study officially began this week and will assess subjective and autonomic effects aiming to determine the qualitative emotional differences between a combined MDMA and LSD experience, a pure LSD experience and a pure MDMA experience, versus a placebo.

LSD in other Phase 1 clinical trials has demonstrated an acute subjective effect on the serotonin 5-HT2A receptor stimulation, leading to ego dissolution and neuroplasticity. These properties of LSD are thought to have therapeutic effects on patients suffering from mental disorders. However, in some instances unpleasant effects can occur in therapy, causing distress to the subject through acute anxiety.

If MindMed finds the Phase 1 trial results promising, it will work with expert clinicians to undertake patient studies with treatments combining MDMA and LSD for various potential indications and mental disorders. With its recent capital raise resulting in a total of CAD $237.2m (USD $183.8m) raised to date and the essential addition of Robert Barrow as Chief Development Officer, MindMed is well positioned to capitalize on research advancements resulting from groundbreaking studies such as this.

More details on the clinical trial can be found here: https://clinicaltrials.gov/ct2/show/NCT04516902

About MindMed

MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the company’s groundbreaking approach to developing the next-generation of psychedelic inspired medicines and therapies.

MindMed trades on the Canadian exchange NEO under the symbol MMED. MindMed is also traded in the United States under the symbol MMEDF and in Germany under the symbol MMQ. For more information: www.mindmed.co

MindMed Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and performance of Mind Medicine (MindMed) Inc. (“MindMed”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, MindMed’s and its collaborators’ ability to continue to conduct research and clinical programs, MindMed’s ability to manage its supply chain, product sales of products marketed by MindMed and/or its collaborators (collectively, “Products”), and the global economy; the nature, timing, and possible success and therapeutic applications of Products and Product candidates and research and clinical programs now underway or planned; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Product candidates and new indications for Products; unforeseen safety issues resulting from the administration of Products and Product candidates in patients, including serious complications or side effects in connection with the use of MindMed’s Products and product candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict MindMed’s ability to continue to develop or commercialize Products; ongoing regulatory obligations and oversight impacting Products, research and clinical programs, and business, including those relating to patient privacy; uncertainty of market acceptance and commercial success of Products and Product candidates and the impact of studies on the commercial success of Products and Product candidates; the availability and extent of reimbursement of Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; competing drugs and product candidates that may be superior to Products and Product candidates; the extent to which the results from the research and development programs conducted by MindMed or its collaborators may be replicated in other studies and lead to therapeutic applications; the ability of MindMed to manufacture and manage supply chains for multiple products and product candidates; the ability of MindMed’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labelling, distribution, and other steps related to MindMed’s Products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of MindMed to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, other litigation and other proceedings and government investigations relating to MindMed and its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on MindMed’s business, prospects, operating results, and financial condition. Any forward-looking statements are made based on management’s current beliefs and judgment. MindMed does not undertake any obligation to update publicly any forward-looking statement.

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