MindBio Therapeutics Completes Dosing in Phase 2B Trial for Major Depressive Disorder
Vancouver, British Columbia — November 6, 2025 — Leads & Copy — MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6) has completed dosing in its Phase 2B clinical trial for Major Depressive Disorder (MDD) patients.
The trial, along with two previously completed clinical trials, marks a global first in receiving regulatory approvals for take-home use of a psychedelic medicine. The company’s lead drug candidate, MB22001, is a proprietary, titratable microdose formulation of lysergic acid diethylamide (LSD) designed for safe, take-home use.
The microdoses are sub-hallucinogenic, allowing patients to take the drug unsupervised at home. Trials have shown dramatic improvements in patients’ mood and wellbeing without the side effects associated with anti-depressant medications. This model also avoids the disruption to daily activity that is evident with other psychedelic medicine treatment models that require clinic visits and hours of supervised treatment.
MindBio has been developing and testing a scalable, affordable, and accessible take-home self-dosing model using microdosing. The company’s research aims 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 study involving 90 patients with Major Depressive Disorder. Results from this trial will inform the potential progression of MB22001 towards post-Phase 2B commercialization in early and special access programs and Phase 3 clinical trials.
Positive outcomes from this trial would position MindBio as a global developer of advanced take-home psychedelic medicine. The company is among the few psychedelic medicine developers to reach late-stage trials, and it is uniquely the only one to have substantially tested a take-home dosing protocol in randomized controlled trials for several years.
MindBio Therapeutics Corp. Chief Executive Officer Justin Hanka said that this is a pivotal moment for MindBio as it progresses the development of novel treatments for psychiatric conditions towards commercialization. He also mentioned that they look forward to presenting the results of the clinical trial 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.
Source: MindBio Therapeutics Corp.
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