Company, seeing early success, will advance preparations for Phase 2a clinical trial in opioid addiction
NEW YORK, July 28, 2020 /PRNewswire/ -- Mind Medicine (MindMed) Inc. (NEO: MMEDOTCQB: MMEDF), the leading psychedelic pharmaceutical company, has concluded dosing in a Phase 1 Single Ascending Dose (SAD) study of 18-MC. The dosing of 18-MC was well tolerated in humans and will help advance planning for a Phase 2a clinical trial in opioid addiction. Further, the study has not incurred any delays due to the COVID-19 pandemic and the Multiple Ascending Dose (MAD) study is on track according to the original development timeline.
18-MC is a non-hallucinogenic molecule based on the psychedelic substance ibogaine. The study tested doses ranging from 4mg to 16mg twice a day and all participants were evaluated for pharmacokinetics and safety.
MindMed's addiction treatment unit is currently focused on developing novel medicines inspired by psychedelics for addiction to address the growing opioid crisis in both Canada and the United States. The US opioid crisis is estimated to cost the US economy over $500 billion annually.
MindMed Co-Founders and Co-CEOs Stephen Hurst and JR Rahn: "The successful and on-time completion of dosing in this Phase 1 study for 18-MC is an important first step in our company's mission to alleviate systemic societal problems with addiction and mental health using psychedelic inspired medicines. We are very pleased with the initial dosing outcome of this Phase 1 SAD study. It gives our clinical team confidence as we advance preparations to begin our Phase 2a clinical trial and hope for millions of patients suffering from opioid addiction."
MindMed plans to begin the Phase 2a study of 18-MC in opioid addiction by the end of this year.
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 has initiated or is initiating studies to evaluate potential treatments to help patients with ADHD, anxiety, cluster headaches and substance abuse. 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: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 word. 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.