- First-in-human trial to investigate the tolerability, pharmacology, and pharmacokinetics of novel MDMA-like compounds versus a placebo in healthy subjects
- Acute effects of equivalent doses will be compared across the following compounds: MDMA, MDA, Lys-MDMA and Lys-MDA
NEW YORK, Sept. 20, 2022 /PRNewswire/ — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today announced the first patient has been dosed in a Phase 1 investigator-initiated study led by MindMed collaborator Prof. Dr. Matthias Liechti at University Hospital Basel (UHB). The study aims to evaluate the effects of MDMA-like substances, including MDA, Lys-MDMA, Lys-MDA, versus a placebo in healthy volunteers.
“Although amphetamines like MDMA and MDA induce mainly positive subjective and mood-enhancing effects, they may also produce negative subjective drug effects, particularly at the onset of response,” said Prof. Matthias Liechti, principal investigator of the trial. “Lys-MDMA and Lys-MDA are prodrugs that are slowly metabolized to MDMA and MDA, offering a novel and controlled delivery system of these active substances with potentially improved pharmacological properties. By using pharmacokinetics and modern psychological and psychometric tests, this study will investigate the potential to better control the bioavailability, slow the effect onset and reduce possible adverse effects of MDMA and MDA by using these prodrugs. The study will also investigate effects of MDA in direct comparison with MDMA for the first time in humans.”
Dr. Miri Halperin Wernli, Executive President of MindMed, added, “This study represents an exciting opportunity to investigate the pharmacokinetic and pharmacodynamic activity of MDMA-like compounds within the same subject. Through our collaboration with the Leichti Lab at UHB, we have exclusive rights to the data from this study which will enhance our understanding of the therapeutic properties involved in the induction of positive mood in a way that may help optimize the treatment model for our R(-)-MDMA drug candidate.”
The Phase 1 clinical trial is a randomized, placebo-controlled, double-blinded, 5-period crossover study. The trial plans to enroll 24 healthy subjects who will receive MDMA (100mg), MDA (93.9mg), Lys-MDMA (171.7 mg), Lys-MDA (165.6 mg), and placebo. The primary outcome measures for this study will assess acute subjective effects using Visual Analog Scales (VAS) assessing the intensity and duration of subjective effects on a scale (0-100 percent) with higher scores representing more intense effects as well as plasma levels of MDMA and MDA at each study day across the 18-month study period. More information about the trial is available on our website (mindmed.co) or on clinicaltrials.gov (identifier NCT04847206).
MindMed is a clinical stage biopharmaceutical company developing novel products to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine, and acetylcholine systems.
MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.
Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and is therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding anticipated upcoming milestones and studies, results and timing of clinical studies, and continuing collaborations and partnerships. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and its Quarterly Reports on Form 10-Q for the period ended June 30, 2022 under headings such as “Special Note Regarding Forward-Looking Statements,” and “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise.
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SOURCE Mind Medicine (MindMed) Inc.