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.