MindMed Announces Successful Completion of Pre-IND Meeting with the FDA for Project Lucy
Provides Clinical Development Update on 18-MC
- Based on positive pre-IND meeting with U.S. Food and Drug Administration (FDA), MindMed is now prepared to open an Investigational New Drug (IND) in August 2021 with a Phase 2b clinical trial for LSD assisted therapy in anxiety
- MindMed continues dose escalation of 18-MC in Phase I SAD/MAD; Meeting confirmed with FDA
NEW YORK, Dec. 14, 2020 /PRNewswire/ -- MindMed (NEO: MMED, OTCQB: MMEDF, DE: MMQ), a leading psychedelic medicine biotech company today announced the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of lysergic acid diethylamide (LSD) assisted therapy for an anxiety disorder.
The successful completion of this engagement with the FDA is an important milestone for the company and provides regulatory clarity and confidence as MindMed advances its lead clinical development program in the U.S. MindMed intends to open the IND with the FDA in August 2021, with a Phase 2b clinical trial evaluating experiential doses of LSD in an anxiety disorder.
MindMed Co-Founder & Co-CEO J.R. Rahn said "The FDA is one of the most impactful organizations for regulated drug development globally. We look forward to working through the FDA pathway on psychedelic assisted therapies in strict compliance with their proven drug development guidelines and commencing our Phase 2b trial for Project Lucy in 2021."
18-MC (Project Layla) Phase 1 Clinical Development Update
Preliminary data has been analyzed for MindMed's addiction treatment program evaluating the ibogaine derivative 18-MC, which the company has named Project Layla. The preliminary data from the Phase 1 Multiple Ascending Dose (MAD) and Single Ascending Dose (SAD) study has shown that the drug is safe and well tolerated at the doses tested to date, and no Serious Adverse Events (SAEs) have been reported.
Based on the excellent safety profile observed to date, MindMed's clinical team and 18-MC's Medical Director, Dr. Judy Ashworth, have decided to continue dose escalation in the study to gather higher dosing data. Once that additional data has been reviewed, MindMed will directly thereafter initiate the Phase 2a proof of concept study. A meeting with the FDA has been confirmed to continue discussions regarding the 18-MC clinical development plan.
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.
SOURCE Mind Medicine (MindMed) Inc.
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