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Patients meeting the selection criteria are currently being pre-screened for entry into the Phase 2 Depression trialEthics and clinical trials registry approvedWorld first take-home approvals for LSD-Microdosing in clinical trials
VANCOUVER, BC / ACCESSWIRE / July 19, 2023 / MindBio Therapeutics Corp. (CSE:MBIO)(Frankfurt:WF6), (the “Company” or “MindBio”), is pleased to have started pre-screening for participant entry into Phase 2 LSD-Microdosing clinical trials. The clinical trials are a world first with approvals for take home use of MindBio’s LSD-Microdosing treatment. The initial Phase 2a open label trial will assess the treatment in patients with Major Depressive Disorder for 8 weeks.
MindBio’s LSD-Microdosing clinical trials to date have yielded positive top line data such as improved quality of sleep including REM and total time of sleep and statistically significant enhancements in subjective feelings of “wellness”, “creativity”, “happiness”, “social connectivity” and “energy”. Participants in the LSD-Microdosing group also reported statistically significant feelings of being less “angry” and less “irritable”. The data collected from the trial adds to MindBio’s intellectual property in a Big Data play for the Company.
MindBio has developed proprietary formulations for microdosing including safe delivery solutions for ease of prescription and safe home use and a digital intervention for monitoring and collecting live biometric data whilst clinical trial participants take their LSD-Microdoses at home. The Company’s Big Data strategy is to commercialize microdosing treatments with a package of proprietary solutions for safe and effective at home use of psychedelics. MindBio remains the only organization in the world approved for take-home use of LSD-Microdosing in clinical trials providing it with a global first mover advantage. The take home approvals are vital for testing the ecological validity of MindBio’s proprietary solutions as the Company progresses its commercialization strategy for global regulatory approvals.
Co-founder and Chief Executive Officer of MindBio Therapeutics Justin Hanka said “We are excited to be progressing our LSD-Microdosing protocols through to Phase 2 clinical trials in patients with Major Depressive Disorder. The positive data we have collected to date is highly encouraging for targeting depressed patients with diminished mood and disrupted sleep”.
MindBio’s investment thesis, using microdosing, centers on the creation of a unique treatment model that is globally scalable, safe, accessible, and affordable, aiming to address the existing challenges in mental health care and also caters for the diversity of medical regulatory regimes around the world.
We invite you to join us in support of creating a brighter future for mental health.
Receive our latest updates here: https://www.mindbiotherapeutics.com/get-updates
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For further information, please contact:
Justin Hanka, Chief Executive Officer
61 433140886
[email protected]
About MindBio Therapeutics
MindBio is a biotech/biopharma company focused on creating novel and emerging treatments for mental health conditions and is conducting world first take-home LSD-Microdosing human clinical trials. MindBio is a leader in microdosing of psychedelic medicines and is advancing its drug and technology protocols through clinical trials. MindBio has developed a multi-disciplinary platform for developing treatments and is involved in psychedelic medicine development and digital therapeutics, has completed Phase 1 clinical trials microdosing Lysergic Acid Diethylamide (LSD) in 80 patients, has a Phase 2 clinical trial in development microdosing LSD in patients with Major Depressive Disorder and a Phase 2 clinical trial in development microdosing LSD in late stage cancer patients experiencing existential distress. MindBio invests in research that forms the basis for developing novel and clinically proven treatments including digital technologies and interventions to treat debilitating health conditions such as depression, anxiety and other related mental health conditions.
Cautionary Note Concerning Forward-Looking Statements:
The press release contains “forward-looking statements” within the meaning of applicable securities laws. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “budget,” “believe,” “project,” “estimate,” “expect,” “scheduled,” “forecast,” “strategy,” “future,” “likely,” “may,” “to be,” “could,” “would,” “should,” “will” and similar references to future periods or the negative or comparable terminology, as well as terms usually used in the future and conditional. Forward-looking statements are based on assumptions as of the date they are provided. However, there can be no assurance that such assumptions will reflect the actual outcome of such items or factors.
Additionally, there are known and unknown risk factors that could cause the Company’s actual results and financial conditions to differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important risk factors that could cause actual results and financial conditions to differ materially from those indicated in the forward-looking statements, include among others: general economic, market and business conditions in Canada and Australia; market volatility; unforeseen delays in timelines for any of the transactions or events described in this press release. All forward-looking information is qualified in its entirety by this cautionary statement.
The Company disclaims any obligation to revise or update any such forward-looking statement or to publicly announce the result of any revisions to any of the forward-looking information contained herein to reflect future results, events or developments, except as required by law.
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SOURCE: MindBio Therapeutics
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