Vancouver, British Columbia – TheNewswire - Nov 6, 2025 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a clinical stage biopharma company developing novel take-home microdose formulations for treating depressive disorders, is delighted to announce dosing in its landmark Phase 2B clinical trial in patients with Major Depressive Disorder (MDD) has completed.

The trial and the Company’s two previously completed clinical trials are world firsts, to have received regulatory approvals for the take-home use of a psychedelic medicine, in this case the Company’s lead candidate drug MB22001.   MB22001 is a proprietary, titratable microdose formulation of lysergic acid diethylamide (LSD) which has been designed for safe, take-home use.  The microdoses are sub-hallucinogenic such that patients can take the drug without supervision at home, and in trials to date patients have been able to successfully go about their day feeling dramatic improvements in their mood and wellbeing without the side effects seen in anti-depressant medications, nor the disruption to daily activity evident with other psychedelic medicine treatment models which all currently require a visit to a clinic and hours of supervised treatment.

MindBio has been developing and testing a scalable, affordable and accessible take-home self dosing model using microdosing as its baseline thesis for investing in clinical research to develop MB22001 as an effective replacement for first line anti-depressants in depression treatment.  

The completed trial is a triple blind, double dummy active placebo-controlled trial in 90 patients with Major Depressive Disorder, the results of which will be informative for potentially progressing MB22001 towards post Phase 2B commercialisation in early and special access programs around the world and Phase 3 clinical trials.

Positive outcomes from this trial would position MindBio globally as the developer of the most advanced take-home psychedelic medicine.  MindBio stands among the few psychedelic medicine development companies to reach late stage trials — yet it is uniquely the only one to have substantially and successfully tested for several years, a take-home dosing protocol in randomised controlled trials.

Chief Executive Officer of the Company, Justin Hanka said “This is a pivotal moment for MindBio as we progress the development of novel treatments for psychiatric conditions towards commercialisation.  We look forward to presenting the results of this important clinical trial which is expected shortly”.

 

For further information, please contact:

 

Justin Hanka, Chief Executive Officer

61 433140886

justin@mindbiotherapeutics.com

  

About MindBio Therapeutics

 

MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6) is a clinical-stage biopharmaceutical company headquartered in Vancouver, British Columbia, focused on developing novel psychedelic-based medicines for mental health disorders. With a commitment to scientific rigor and patient accessibility, MindBio is pioneering the use of regulated, take-home use of microdoses of psychedelic medicines in clinical trials to provide safe, effective, and scalable treatments for conditions such as depression, anxiety, and other psychological challenges. The company’s mission is to improve global mental health outcomes through innovative, evidence-based treatment that is accessible and affordable.

 

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