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MindBio Therapeutics Breakthrough Discovery in Microdosing Clinical Trial Reveals Significant Positive Effects on Quality Of Sleep

  • New Discovery: MindBio's LSD-Microdosing Treatment Improves Sleep

  • Significant Intellectual Property Advancement & Know How

  • Completed: Extensive Analysis of LSD-Microdosing Data from 3231 Nights of Sleep

  • Statistically Significant Results: MindBio is pleased to report statistically significant improvements in quality of sleep discovered in the LSD-Microdosing group vs Placebo group

VANCOUVER, BC / ACCESSWIRE / June 14, 2023 / MindBio Therapeutics Corp. (CSE:MBIO)(Frankfurt:WF6), (the "Company" or "MindBio"), is pleased to report its major discovery from sleep data obtained from randomized controlled trials LSD-Microdosing from 3231 nights of sleep in 80 clinical trial participants.

MindBio Therapeutics, Wednesday, June 14, 2023, Press release picture
MindBio Therapeutics, Wednesday, June 14, 2023, Press release picture

MindBio's LSD-Microdosing clinical trials have yielded positive top line data including statistically significant enhancements in subjective feelings of "wellness", "creativity", "happiness", "social connectivity" and "energy". The sleep data collected from the trial adds to MindBio's intellectual property in a Big Data play for the Company. MindBio scientists are preparing a further 7 subsequent upcoming papers analysing data from Phase 1 LSD-Microdosing randomized controlled trials in 80 healthy subjects ahead of two Phase 2 LSD-Microdosing trials starting shortly.

MindBio is pleased to report preliminary findings from sleep data obtained from 3231 nights of sleep, recording, measuring and analysing the sleep patterns of participants in the LSD-Microdosing treatment group n=40 against the placebo group n=40. The Company is pleased to announce it has made a major discovery confirmatory of positive sleep responses to MindBio's LSD-Microdosing treatment. Not only does LSD-Microdosing improve subjective feelings of mood and feelings of happiness, energy, creativity, social connectivity and wellness, it also has a statistically significant impact on quality of sleep.

Why is positive sleep data from LSD-Microdosing so important?

The ground-breaking findings are important, particularly in depression, and some related mental health conditions where MindBio has a scientific interest, such as pre-menstral dysmorphic disorder, where quality of sleep is disproportionately compromised and seen as a significant contributor to down-spiralling mental health. A common first line of treatment to mood and sleep disruption is the use of anti-depressants plus sleeping pills. Sleeping pills pose a potential reliance, misuse and addiction risk and the negative unacceptable side effects from anti-depressants (such as weight gain, agitation, gastro-intestinal upset and sexual impotence) are well reported.1 The positive sleep data from MindBio's proprietary LSD-Microdosing treatment is ground-breaking in respect of potentially replacing existing treatments for mood and sleep disruption that are often ineffective and have unacceptable side effects. MindBio's discovery adds to the Company's Big Data strategy, adding to its intellectual property to effectively treat patients with mental health disorders through MindBio's proprietary LSD-Microdosing treatment program.

Phase 2 LSD-Microdosing trials to begin shortly.

MindBio has two fully funded Phase 2 LSD-Microdosing clinical trials starting shortly. The first trial focuses on Major Depressive Disorder, where 20 patients meeting DSM-V criteria will receive an open label 8-week LSD microdosing treatment regimen in a naturalistic at-home setting. This trial will serve as the basis for continuing a much larger Phase 2b triple-dummy, active placebo-controlled trial in depressed patients. The second trial explores the effectiveness of LSD-Microdosing in conjunction with Meaning Centred Psychotherapy in late-stage cancer patients experiencing emotional distress. This randomized, double-blind, and placebo-controlled trial will involve 40 participants and is set to begin recruiting participants for the trial shortly.

Chief Executive Officer and Co-Founder of MindBio Therapeutics said "We are delighted by the continued progress we see in the effectiveness and tolerability of MindBio's proprietary LSD-Microdosing program. The sleep data is promising for a potential tolerable alternative to sleeping pills and we are rigorously pursuing masses of data on LSD-Microdosing under randomized controlled conditions to get the evidence we need for accelerating approvals for access to this medicine for effectively treating mood and sleep disruption".

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.

We invite you to join us in support of creating a brighter future for mental health.

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Justin Hanka, Chief Executive Officer

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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.

Neither the Canadian Securities Exchange nor its Regulation Service Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE: MindBio Therapeutics

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