MindMed Receives Approval of Protocol Design to Evaluate Microdoses of LSD For Adult ADHD In Phase 2a Clinical Trial from Swiss and Dutch Health Authorities
Project Lucy Submits Pre-IND Briefing Package to the FDA; Agrees Q1 Interim Analysis of Swiss Phase 2a Trial of LSD Assisted Therapy for Anxiety Disorders
NEW YORK and BASEL, Switzerland, Nov. 16, 2020 /PRNewswire/ -- MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company, has received a positive response on its protocol design for a Phase 2a clinical trial evaluating microdoses of LSD in the treatment of adult ADHD from the Swiss and Dutch health authorities. MindMed has also successfully submitted a pre-IND briefing package to the FDA for its Project Lucy, a potential Phase 2b Efficacy Trial evaluating LSD Assisted Therapy in anxiety disorders. In addition, the company has now reached an agreement with University Hospital Basel Liechti Lab to conduct an interim analysis anticipated in Q1 2021 for its Phase 2a clinical trial of LSD assisted therapy for anxiety disorders currently ongoing in Switzerland.
Microdose LSD Positive Regulatory Response
MindMed's Phase 2a Proof of Concept study evaluating microdoses of LSD for the treatment of Adult ADHD has successfully reached an agreement on the study protocol with both the Swiss and Dutch health authorities. MindMed is working with our site coordinators in Switzerland and the Netherlands on our patient recruitment strategy and will provide updates on recruitment progress in due course. MindMed anticipates dosing to begin in patients in the second half of next year at both of our sites in Basel, Switzerland and Maastricht, Netherlands. MindMed's clinical and technical operation teams are in the process of producing and preparing the GMP LSD material necessary to begin dosing for the Phase 2a commercial drug trial.
J.R. Rahn, MindMed co-founder and co-CEO said: "We are very pleased with the positive response from the Swiss and Dutch regulators on our protocol design evaluating microdoses of LSD for Adult ADHD in our planned Phase 2a trial. Our team has been working diligently to prepare this trial and we are very excited to begin recruitment and plan on dosing ADHD patients in the second half of 2021."
MindMed's microdosing division is now evaluating the potential for additional microdosing technologies as part of our R&D efforts and growing its portfolio of microdose-related clinical trials.
Submission of Pre-IND Briefing Package to the FDA
MindMed's clinical and regulatory team has recently completed a pre-IND briefing package and submitted it last week to the FDA in preparation for a pre-IND call with the FDA in December. Data from a recently completed Phase 1 dose range finding study by the Liechti Lab together with multiple other Phase 1 studies conducted both in patients and healthy volunteers over the past 10 years helped define the dosing regimen proposed by MindMed to the FDA for the proposed Phase 2b clinical trial.
These efforts at FDA and our clinical strategy for LSD are being led by MindMed President Dr. Miri Halperin Wernli and her team of drug development experts and scientific collaborators. Dr. Halperin Wernli added: "Our team worked very diligently throughout the third quarter to prepare the pre-IND briefing package, drawing on support from many of our scientific collaborators and domain experts. We hope to open the IND for this Phase 2b trial and to begin treating patients in 2021."
Swiss Phase 2a Study Interim Analysis
MindMed was able to agree with the Liechti Lab and receive approval from the ethics committee at the University Hospital Basel to undertake an interim readout and analysis of the Phase 2a study using LSD assisted therapy for anxiety disorders being conducted in Switzerland by Dr. Matthias Liechti and Dr. Peter Gasser. MindMed in partnership with the Liechti Lab will conduct this interim analysis of the Phase 2a clinical trial data in Q1 2021. The study has been ongoing for close to four years and MindMed eagerly awaits the analysis and results from the interim readout of the study.
MindMed maintains an exclusive license to this Phase 2 study as part of our license agreement with the University Hospital Basel. More info on the trial can be found here:
https://clinicaltrials.gov/ct2/show/NCT03153579?term=Basel+lsd&draw=2&rank=7
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.
This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the United States. The securities of the Company will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons except in certain transactions exempt from the registration requirements of the U.S. Securities Act)
SOURCE Mind Medicine (MindMed) Inc.
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