Phase 1 Trial to experiment with dosing methods to better understand how humans react to DMT, setting stage for future potential Phase 2a proof of concept trials
BASEL, Switzerland, June 18, 2020 /PRNewswire/ -- MindMed will now pursue N,N-Dimethyltryptamine (DMT), the principally active ingredient in Ayahuasca, as part of its R&D collaboration with the University Hospital Basel's Liechti Lab. MindMed is providing startup funding for a Phase 1 clinical trial testing various intravenous dosing regimens of DMT, expected to begin in Q4 of 2020.
DMT is a naturally-occurring psychedelic substance and is the active ingredient used in Ayahuasca ceremonies by indigenous Amazonian shamanic practitioners. DMT causes a rapid onset and offset of action compared to similar psychedelic substances such as psilocybin or LSD. When administered as an Ayahuasca brew, natural substances are mixed with DMT to prolong its experiential effects and slow the metabolism in the human body.
MindMed Co-Founder & Co-CEO JR Rahn said: "There is a growing trend in Western society to use Ayahuasca and DMT to facilitate a healing process for one's mind. However, there is very limited safety data and clinical trials evaluating DMT as a potential medicine so we are going to double down on understanding the therapeutic opportunity and more effective ways to administer DMT in a controlled setting to achieve this healing process."
Through this Phase 1 clinical trial, MindMed and the Liechti Lab are exploring how DMT can achieve experiential effects similar to Ayahuasca by testing a more controlled intravenous dosing method.
There is non-clinical, anecdotal evidence which suggests DMT and Ayahuasca's experiential effects are powerful healing tools for addiction disorders. The human safety data and associated knowhow gathered in this Phase 1 clinical trial will better enable MindMed's clinical team to design future potential commercial drug development programs based on DMT sessions.
DMT is rapidly metabolized as it enters the body if taken orally and therefore it only has a very short duration of action. In contrast through a continuous intravenous perfusion application the effect is longer but can be stopped rapidly. In order to potentially induce a stable DMT experience lasting 1-2 hours, an intravenous dosing regimen including a starting dose and then a maintenance dose will be evaluated in this Phase 1 clinical trial. This intravenous administration may also allow therapists to induce and to end an experiential state safely and more quickly as required.
Currently, no study has validly determined the elimination half-life of DMT and other pharmacokinetic parameters and there is limited known data on dosing regimens of pure DMT. This Phase 1 double blind placebo controlled 5-period crossover design study will provide a well controlled study setting to illuminate these shortcomings in the current clinical understanding of DMT and pave the way for future Phase 2a proof of concept efficacy studies in various indications.
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:BGHM. 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 the future performance of Mind Medicine (MindMed) Inc. ("MindMed" or the "Company"), 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 (including those discussed in this press release), MindMed's ability to manage its supply chain, net product sales of products marketed by MindMed and/or its collaborators (collectively, "MindMed's Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of MindMed's 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 MindMed's product candidates and new indications for MindMed's Products; unforeseen safety issues resulting from the administration of MindMed's 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 MindMed's Products and product candidates; ongoing regulatory obligations and oversight impacting MindMed's Products, research and clinical programs, and business, including those relating to patient privacy; uncertainty of market acceptance and commercial success of MindMed's Products and product candidates and the impact of studies (whether conducted by MindMed or others and whether mandated or voluntary) on the commercial success of MindMed's Products and product candidates; the availability and extent of reimbursement of MindMed's 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; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to MindMed's 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 the Company and/or 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, and the reader is cautioned not to rely on any forward-looking statements made by MindMed. MindMed does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Tel: + (212) 254-4730
SOURCE Mind Medicine (MindMed) Inc.