MINDBIO (CNSX:MBIO) COMPLETES WORLD FIRST TAKE HOME PHASE 2 MICRODOSING DEPRESSION TRIAL
Feb 14, 2024 9:19 am
Hi
I am delighted to share with you that MindBio Therapeutics Corp (CNSX: MBIO) has completed its landmark Phase 2a take home microdosing 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.
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 an 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.
We invite you to join us in support of creating a brighter future for mental health.
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Stay tuned and Stay Well!
JUSTIN HANKA
Co-Founder & Chief Executive Officer
MindBio Therapeutics Corp (CNSX: MBIO)