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Data to Support MindMed's Project Lucy in Preparing Phase 2b Trial for Anxiety Disorders
- MindMed (NEO: MMED, OTCQB: MMEDF), the leading psychedelic medicine biotech company in partnership with University Hospital Basel's Liechti Lab announces the completion and publication of a Phase 1 study on the acute dose dependent effects of LSD. The completed Phase 1 study will help MindMed in dose-finding and the planning of future Phase 2 clinical trials of LSD in patients with anxiety disorders and other medical conditions.
Specifically, the Phase 1 study measured LSD dose-dependently induced subjective responses starting at microdoses (25 ug) up to experiential doses (200 ug). Maximal good drug effects were reached at a 100 ug dose. However, an experiential dose of 200 ug LSD was shown to induce greater ego dissolution than a lesser 100 ug dose. Ego-dissolution is thought to be one of the key therapeutic potentials of the psychedelic experience and psychedelic assisted therapy process.
MindMed's team is actively preparing Project Lucy which intends to evaluate the efficacy of LSD assisted therapy for anxiety disorders in a Phase 2b clinical trial.
MindMed's Co-Founder and Co-CEO, J.R. Rahn , commented on the results, "We see this now completed study as an important stepping stone with highly relevant data to support Project Lucy as the team identifies optimal dose levels of LSD to test in the intended Phase 2b trial of an anxiety disorder. As COVID-19 continues to compound society's prevalence of anxiety disorders globally, MindMed is pushing ahead with full vigor on the planning and design of Project Lucy."
MindMed and University Hospital Basel are actively filing patent applications on clinical trial data generated through the collaboration's numerous clinical trials and R&D. MindMed maintains an exclusive license to the data and IP generated through its continued research collaboration and licensing agreement with the Liechti Lab at University Hospital Basel.
The Phase 1 study used a double-blind, randomized, placebo-controlled, crossover design in 16 healthy participants (eight women, eight men) who underwent six 25 h trial sessions and received placebo, LSD (25, 50, 100, and 200 µg), and 200 µg LSD 1 h after administration of ketanserin (40 mg). LSD showed dose-proportional pharmacokinetics and first-order elimination.
In addition, effects of the high 200 µg dose of LSD were effectively prevented by a pretreatment with the 5-HT2A receptor antagonist ketanserin indicating that psychedelic effects of LSD are primarily mediated by serotonin 5-HT2A receptor activation.
The study was published in Neuropsychopharmacology, which is an international scientific journal and the official publication of the American College of Neuropsychopharmacology (ACNP)
The publication can be found here : https://www.nature.com/articles/s41386-020-00883-6#Sec20
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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SOURCE Mind Medicine (MindMed) Inc.
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