MindBio Enrols 80th Participant into Landmark Phase 2B Depression Trial as Trial Nears Completion.
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A Brighter Future for Mental Health
CSE: MBI
Vancouver, British Columbia – May 19, 2025 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (“MindBio”), (the “Company”), a clinical-stage biopharmaceutical company dedicated to developing novel and effective mental health treatments, is pleased to announce the enrolment of the 80th participant in its landmark Phase 2B clinical trial evaluating MB22001 for Major Depressive Disorder (MDD). This milestone underscores MindBio’s enduring commitment to developing innovative, accessible, affordable and commercially scalable treatments to address the global mental health crisis.
MB22001, MindBio’s proprietary, titratable formulation of lysergic acid diethylamide (LSD) designed for safely monitored, take-home microdosing, has shown a robust safety, adherence, and tolerability profile across thousands of self-administered doses under randomized controlled conditions. This Phase 2B trial, in 90 patients with Major Depressive Disorder is an 8-week triple blind, double dummy, active placebo-controlled trial. The sub-hallucinogenic microdoses administered in this innovative trial design, allow patients to seamlessly integrate the treatment into their daily lives, offering a practical, convenient and commercially scalable alternative to clinic-based, high-dose psychedelic therapies.
Emerging data from MindBio’s Phase 1 and Phase 2A trials, and now in multiple Phase 2B trials, continues to support MB22001’s potential as a safe and effective treatment for depression, providing new hope for patients worldwide. Most notably, clinical trials have shown statistically significant and clinically meaningful improvements in mood, quality of life, sleep (including REM sleep time), anxiety and depression. After an 8-week open label trial, in 20 patients with MDD, MindBio scientists observed a 72% improvement in depressive symptoms sustained 6-months post cessation of treatment.
Having just completed its final independent safety committee audit, the trials have been given the go ahead to continue to completion, which is a total of 90 participants, with all participants in the placebo group, in parallel, having the opportunity to trial MB22001 in an 8-week open label extension. The Company is looking forward to presenting initial top line results of the trials later in 2025.
MindBio remains the only organization in the world to have secured regulatory approvals for at-home patient administered dosing of this type of medicine now in multiple Phase 2B clinical trials. The trial design replicates real world conditions by enabling patients to self-administer MB22001 microdoses at home, empowering patients to manage their condition without the time and cost burdens associated with clinic-based psychedelic treatments. The Company is developing MB22001 as the most advanced take-home use case of psychedelic medicines in late-stage clinical trials anywhere in the world.
In addition to the ongoing depression trial, MindBio is actively dosing participants in a second Phase 2B trial for cancer-related existential distress, further demonstrating the versatility of its therapeutic platform. The company also recently received approval for a third Phase 2B trial targeting Pre-Menstrual Syndrome (PMS) and Pre-Menstrual Dysphoric Disorder (PMDD), with plans to commence dosing pending strategic funding partnerships. MindBio is actively engaging with investors to support this trial, which aims to address another critical unmet need in women’s mental health.
“Enrolling the 80th participant in our Phase 2B depression trial marks a significant step forward in our mission to transform mental health treatment,” said Justin Hanka, Chief Executive Officer of MindBio Therapeutics. “MB22001 represents a paradigm shift in depression treatment, offering a scalable, affordable, and patient-centric solution. We are deeply encouraged by the progress of our clinical programs and remain committed to advancing psychedelic medicine for the benefit of patients globally.”
MindBio’s innovative approach to microdosing psychedelic medicines is poised to redefine the treatment landscape for mental health disorders. By prioritizing accessibility and affordability, the company aims to deliver a globally scalable solution that addresses the systemic challenges of traditional mental health interventions.
MindBio invites stakeholders, partners, and the global community to join in supporting its vision for a brighter future in mental health.
About MindBio Therapeutics
MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6) is a clinical-stage biopharmaceutical company, 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 microdosing 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.
Follow MindBio on LinkedIn: https://www.linkedin.com/company/mindbio-therapeutics/?viewAsMember=true
Follow CEO Justin Hanka on LinkedIn: https://www.linkedin.com/in/justinhanka/
For further information, please contact:
Justin Hanka, Chief Executive Officer
61 433140886
Media Inquiries
Kristina Spionjak
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