MindBio Therapeutics Receives Final Regulatory Approval to Conduct Phase 2B Randomised Controlled Trial Microdosing Mb22001 in Patients Diagnosed with Major Depressive Disorder

Ethics and regulatory approvals finalized for world-first take-home use of a psychedelic medicine MB22001 in placebo-controlled trial in depressed patients n=90

Recruitment of clinical trial participants underway

Follows successful Phase 2a trial where 53% of depressed patients in complete remission at week 8 of treatment

Prior trials of MB22001 show statistically significant improvements in sleep and mood

VANCOUVER, BC / ACCESSWIRE / March 4, 2024 / MindBio Therapeutics Corp. (CSE:MBIO)(Frankfurt:WF6), (the "Company" or "MindBio") is pleased to announce final regulatory approvals have been received for a world's first Phase 2B randomized controlled take home clinical trial microdosing MB22001 in patients with Major Depressive Disorder. The trial has received Ethics approval, has been approved by the Clinical Trials Registry and received final ministerial approval to begin dosing. First dosing will begin on 11 March 2024.

In this Phase 2B Randomized, triple blind and active placebo controlled trial, patients with major depressive disorder (MDD) will undertake an 8 week regimen of MindBio's lead candidate drug, MB22001, a proprietary titratable and self-administered form of Lysergic Acid Diethylamide (LSD) designed for take-home use. In this trial (n=90) half the trial participants will take an active placebo and the other half will take MB22001. All participants will be offered an 8 week extension to ensure the placebo group has the opportunity to experience the treatment resulting in 16 weeks of data being collected from every patient.

Major depressive disorder (MDD) is the leading cause of global disability, with over 260 million people affected. In Aotearoa/New Zealand, the jurisdiction of this study, approximately 6% of persons experience a depressive episode each year. In the US, the Centers for Disease Control and Prevention (CDC) predicts that about 16 million adults in the US will experience depression each year. Despite this prevalence, current medical therapies are limited by slow onset, variable tolerability, with partial or total lack of efficacy in approximately one third of patients¹. Surveys have shown that while people who take antidepressants feel they are helpful for mood, many report problems with drug withdrawal (74%), sexual dysfunction (72%), weight gain (65%), and emotional numbing (65%), all of which negatively impact quality of life².

In February 2024, MindBio completed its Phase 2a trial in patients with Major Depressive Disorder. In this open label trial, patients experienced a 60% drop in depressive symptoms and 53% of patients entering the trial with MDD, at week 8 were in complete remission from their depression marked by a mean 14.1 point drop in MADRS score (Montgomery-Asberg Depression Rating Scale). Prior trial results using MB22001 recorded statistically significant improvements in sleep quality and increases in subjective feelings of "Happiness", "Social Connectivity", "Energy", "Creativity" and "Wellness" with reduced "Anger" and "Irritability". MB22001 is a promising and potential market disruptive medicine for treating depressive illness.

The depth of data the company has collected is mounting evidence of the effectiveness and safety of MB22001 in treating depressive disorders at scale through take-home use. Extraordinarily, MindBio's unique investment thesis in the sector, is that small, sub-hallucinogenic doses of a psychedelic drug, MB22001 is the most scalable way to use a psychedelic medicine to treat depressive disorders globally. The methodology contrasts the major focus of pharmaceutical companies using large doses and lengthy expensive in-clinic hallucinogenic experiences coupled with extensive psychotherapy to treat these conditions. Whilst those methods are proving to be effective in clinical trials, it is disruptive to a patient's routine, requires time off work and the treatment is expensive potentially making it inaccessible at scale. MindBio's goal is to commercialise MB22001 as an affordable, accessible replacement to first line medications such as anti-depressants with low side effects (particularly no sexual side effects or weight gain) resulting in greater adherence.

MindBio is developing intellectual property in drug formulation and design for practical and safe take-home titratable use of MB22001. And, in a big data play for the company, MindBio is developing precision treatment regimens based on an individual's unique medical presentation. MindBio is the only organization in the world that has this type of data including extensive psychometric testing, mRNA, DNA, PK, PD, Biometric Markers, Activity Data and Sleep Data collected in the real world and approved by regulators for take home microdosing. Whilst the top line statistical reporting of data and the clinical trial protocols are shared openly and trial results published in peer reviewed scientific journals, the extensive data sets are proprietary and not visible or available for use by competitors. MindBio is building a defensive moat around its intellectual property including extensive data collection and analytics related to microdosing, with the ultimate view on competitively commercializing MB22001 directly against anti-depressants.

Chief Executive Officer of MindBio Therapeutics, Justin Hanka said "Microdosing MB22001 is a disruptive treatment methodology, it represents a scalable, affordable and accessible solution using psychedelics to address the global escalation of depression. This is a potential market disruption to first line treatments for depression. We are the global leaders in psychedelic microdosing and we are strategically positioning MB22001 to replace anti-depressant use with lower side-effects."

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For further information, please contact:

Justin Hanka, Chief Executive Officer
61 433140886
justin@mindbiotherapeutics.com

Media Inquiries

Kristina Spionjak
pr@hlthcommunications.com

References:

1. Warden, D., Rush, A. J., Trivedi, M. H., Fava, M., & Wisniewski, S. R. (2007). The STAR*D Project results: a comprehensive review of findings. Curr Psychiatry Rep, 9(6), 449-459. http://www.ncbi.nlm.nih.gov/pubmed/18221624
2. Cartwright, C., Gibson, K., Read, J., Cowan, O., & Dehar, T. (2016). Long-term antidepressant use: patient perspectives of benefits and adverse effects. Patient Prefer Adherence, 10, 1401-1407. https://doi.org/10.2147/ppa.S110632

About MindBio Therapeutics

MindBio is a leading biotech/biopharma company focused on creating novel and emerging treatments for mental health conditions and is conducting world first take-home Microdosing (MB22001) human clinical trials. MB22001 is MindBio's lead candidate drug, a proprietary titratable form of Lysergic Acid Diethylamide (LSD) designed for take-home microdosing. 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 in 80 healthy partipicipants, has a Phase 2a clinical trial just completed microdosing in patients with Major Depressive Disorder and a Phase 2B clinical trial currently underway microdosing 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.

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SOURCE: MindBio Therapeutics