MindMed announced a randomised, placebo-controlled study to evaluate the effects of microdosing LSD on:
- cognitive performance
- sleep quality
- emotion regulation
- quality of life
- immune system response
The study will be conducted in collaboration with Maastricht University’s Dr. Kim Kuypers, and will be integrated into MindMed’s newly-formed Albert digital therapeutics division. Specifically, digital tracking devices and software will be utilised to better understand LSD’s effects on various clinical markers.
Additionally, the Company’s Microdosing Division is undertaking a Phase 2a clinical trial evaluating microdoses of LSD for ADHD.
Full news release…
MindMed to Commence Groundbreaking LSD Microdosing Study Evaluating Benefits on Neuroplasticity, Sleep, Cognitive Enhancement Variables and Immune System Response on the Human Body
NEW YORK, Jan. 12, 2021 /CNW/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced an innovative randomized placebo-controlled study evaluating the effects of daytime and evening administration of low doses of LSD on cognitive performance, sleep quality, mood, neuroplasticity markers, emotion regulation, quality of life, and immune system response.
The study will provide an additional research pathway for MindMed’s psychedelic Microdosing Division and will immediately integrate with MindMed’s plans in digital therapeutics through its newly formed Albert unit for digital medicine. The new study will be conducted in collaboration with Dr. Kim Kuypers of Maastricht University in the Netherlands, a global, leading authority on the microdosing of psychedelics.
Dr. Kuypers said, “I am excited about this new study which combines a variety of measures ranging from self-reporting and cognitive tasks to health and sleep parameters, bringing us closer to the mechanism of action behind the claimed benefits of microdosing.”
In order to advance the scientific understanding of microdosing for clinical purposes, the randomized placebo-controlled study will specifically measure the effects of microdoses of LSD on neuroplasticity markers such as BDNF plasma levels, as well as on various sleep measures, mood, cognitive performance, emotion regulation, quality of life, and immune system response. MindMed is integrating innovative digital tracking devices and software into the study to better assess LSD’s effects on various digital clinical markers on the human body.
MindMed’s President and Head of Clinical, Dr. Miri Halperin Wernli, commented on the groundbreaking new study saying, “Over the past 15 years there has been growing interest in psychedelic microdosing and its potential enhancing effects on the human body. We now aim to use digital medicine techniques to expand the measurements enabling us to track and understand cognitive performance, various behavioral variables, productivity, and mood indicators. We believe that such measurements may offer an efficient way of determining a response loop for better understanding how microdosing can affect the human body. With this study we are seeking to gather scientific and controlled data that we hope will contribute to the discovery of potential therapeutic applications for these psychedelics microdosing paradigms as innovative treatment modalities.”
In addition to this study, MindMed’s Microdosing Division under the leadership of Dr. Halperin Wernli is undertaking a commercial Phase 2a Adult ADHD clinical trial evaluating microdoses of LSD. Dr. Kim Kuypers and Dr. Matthias Liechti will serve as principal investigators for the initial clinical trial of this commercial program.
MindMed is a leading 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.
For more information:www.mindmed.co
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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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SOURCE Mind Medicine (MindMed) Inc.