Clinical Trials Pipeline

MindBio has a strong and dedicated clinical trials pipeline
across psychedelic drug and technology development.
The Company has multiple Phase 2 Microdosing Projects underway and in development.

Multiple Phase 2B clinical trials underway

Multiple Phase 2B clinical trials underway

Clinical Trials Summary

MB22001

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.

 

We invite you to join us in support of creating a brighter future for mental health.

MINDBIO BEGINS LANDMARK PHASE 2B TAKE-HOME MICRODOSING (MB22001) CLINICAL TRIAL IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER

  • First doses of MB22001 administered in Phase 2B take-home trial in patients with Major Depressive Disorder

  • Follows successful Phase 2A trial where 53% of depressed patients were in complete remission from their depression at week 8 marked by a mean 14.1 point drop in MADRS score (Montgomery-Asberg Depression Rating Scale), a 60% mean drop in depressive symptoms. 

 

Vancouver, British Columbia – 20 March, 2024 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (the “Company” or “MindBio”) is pleased to announce first dosing has begun in a Phase 2B randomized controlled clinical trial microdosing MB22001 in patients with Major Depressive Disorder.

In a world first series of clinical trials, MindBio has secured regulatory and ministerial approvals for MB22001 to be self-administered by participants out in the community and at home. In this Phase 2B randomized, triple blind and active placebo-controlled trial, patients with major depressive disorder (MDD) will undertake an 8 week regimen of MindBio’s lead candidate drug, MB22001, a proprietary titratable and self-administered form of Lysergic Acid Diethylamide (LSD) designed for take-home use.  In this trial (n=90) half the participants will take an active placebo and the other half will take MB22001.  After the 8 week trial, both placebo and drug group participants will be invited to participate in an 8 week open-label extension to ensure the placebo group has the opportunity to experience treatment with MB22001 resulting in potentially 16 weeks of data being collected from every patient.

MindBio’s unique investment thesis in the sector, is that small, sub-hallucinogenic doses of a psychedelic drug, MB22001 is the most scalable way to use a psychedelic medicine to treat depressive disorders globally.  The Company’s goal is to commercialize MB22001 as an affordable, accessible replacement to first line medications such as anti-depressants with low side effects (particularly no sexual side effects, emotional numbness, or weight gain) resulting in greater adherence to the treatment. 

Chief Executive Officer of MindBio, Justin Hanka said “Microdosing MB22001 is a disruptive treatment methodology using psychedelic medicines and our ambition is to develop this treatment globally at scale for affordable access to patients without the limitations and side-effects of common anti-depressants”.

In February 2024, MindBio completed its Phase 2a trial in patients with Major Depressive Disorder.  In this open label trial, patients experienced a 60% drop in depressive symptoms and 53% of patients entering the trial with MDD, at week 8 were in complete remission from their depression marked by an impressive mean 14.1 point drop in MADRS score (Montgomery-Asberg Depression Rating Scale).  Prior trial results using MB22001 recorded statistically significant improvements in sleep quality and increases in subjective feelings of “Happiness”, “Social Connectivity”, “Energy”, “Creativity” and “Wellness” with reduced “Anger” and “Irritability”.  MB22001 is a promising and potential market disruptive medicine for treating depressive illness.

MINDBIO PRESENTS WORLD FIRST PHASE 2B

TAKE-HOME MICRODOSING CLINICAL TRIAL IN CANCER PATIENTS

·      World first – approved for take home in cancer patients experiencing emotional distress

·      MB22001 is a proprietary titratable form of LSD (Lysergic Acid Diethylamide) for convenient take-home Microdosing

Vancouver, British Columbia – October 31, 2023 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), is pleased to announce first doses have been administered in MindBio’s Phase 2B randomised, double blind and placebo controlled clinical trial in patients with advanced stage cancer who are experiencing emotional distress. 

In a world first, this is a Phase 2B government approved take-home trial of a psychedelic medicine (MB22001), a titratable form of LSD, designed for safe dosing in the community.

In this video, MindBio Chief Executive Officer and Co-founder Justin Hanka discusses the trial and the importance of this scientific work for treating depression and existential distress in advanced stage cancer patients.

Chief Executive Officer of MindBio Justin Hanka said, “Patients with advanced stage cancer experience emotional and existential distress and are commonly treated with anti-depressants and anti-anxiolytic medications that are often not effective and or have undesirable side effects.  We hope this treatment provides effective relief of symptoms of depression and anxiety in this vulnerable patient cohort”.