MINDBIO COMPLETES WORLD FIRST TAKE HOME PHASE 2A MICRODOSING DEPRESSION TRIAL

MINDBIO THERAPEUTICS COMPLETES WORLD FIRST TAKE HOME PHASE 2A MICRODOSING DEPRESSION TRIAL

Vancouver, British Columbia – February 14, 2024 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a leading biopharma company in psychiatric medicine development, is delighted to announce the completion of its landmark Phase 2a clinical trial in patients with Major Depressive Disorder.

MindBio has achieved a significant milestone becoming the only organization in the world to have completed a Phase 2a clinical trial with regulatory approvals for take-home use and handling of a psychedelic medicine by trial patients, specifically a proprietary titratable form of Lysergic Acid Diethylamide (LSD) in microdoses called MB22001 has been specifically designed for take home use.

MindBio’s Phase 2a clinical trial in patients with Major Depressive Disorder is an open label trial that looked for clinically significant changes in depression rating scores using a global standard for measuring the severity of depression, the MADRS (Montgomery Asberg Depression Rating Scale).  MB22001 was administered in titratable microdoses to clinical trial participants.  Now that the trial has been completed, the primary end point for assessing the success of MB22001 for the treatment of depression is an improvement in the MADRS.

Chief Executive Officer and Co-founder of MindBio Justin Hanka said “This is a pivotal moment for MindBio as we progress the development of novel treatments for psychiatric conditions.  Our scientific team is processing the vast amount of data from the clinical trial, and we look forward to announcing the results of this important clinical trial expected to be presented in the coming weeks”.

Concurrently, MindBio is also conducting a Phase 2B trial in late-stage cancer patients experiencing existential distress, a common phenomenon experienced at end of life, a mix of depressive, anxiety and distress symptoms that often is treated with anti-depressants.  

The completion of MindBio’s landmark Phase 2a Depression trial comes after the successful completion of its extensive Phase 1 trial in 80 healthy individuals which yielded positive safety and tolerance data as well as statistically significant improvements in mood marked by increases in “energy”, “wellness” “happiness”, “creativity” “social connectivity” and a reduction in “anger” and “irritability”.  We also made a new discovery from sleep data in healthy individuals. We found that MB22001 produced statistically significant improvements in sleep, including REM sleep time, total sleep time and total quality of sleep observed the day after each dose day.

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