MindBio Therapeutics has announced groundbreaking results from a Phase 2a clinical trial involving the take-home microdosing of MB22001 for treating depression.
This world-first trial showcased a significant decrease in depression symptoms over 8 weeks, with a 60% reduction in depressive symptoms and 53% of patients achieving complete remission. The trial achieved its primary efficacy endpoint with an average 14.1 point drop in the Montgomery-Asberg Depression Rating Scale (MADRS), demonstrating the safe and effective use of MB22001 in a take-home setting without any serious treatment-related adverse events.
This marks a pivotal moment for MindBio as it progresses into late-stage pharmaceutical drug development, emphasizing the potential of MB22001, a self-titratable form of Lysergic Acid Diethylamide (LSD) designed for take-home use, in treating depression. The company has been recognized for its unique position in conducting clinical trials with government and regulatory approval for take-home psychedelic medicine use, collecting extensive data over three years to develop a scalable, safe, and effective treatment model for depression.
MindBio’s commitment to advancing mental health treatment options is underscored by its proprietary drug candidate’s ability to be adjusted according to individual tolerance levels, ensuring a tailored and patient-centric approach to depression treatment.
Here is the original press release:
Vancouver, British Columbia – February 26, 2024 – MindBioTherapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio’s”), a leading biopharmaceutical company in psychiatric medicine development, is delighted to announce positive topline data from its world-first take-home microdosing depression clinical trial using MB22001. The completion of this landmark and highly successful Phase 2a clinical trial is a major inflection point for the Company as it moves to late-stage pharma drug development.
“We are delighted to share that MB22001 showed rapid and statistically significant improvements with 60% reduction in depressive symptoms and 53% of patients experiencing complete remission from depression. The treatment resulted in an impressive mean 14.1 point drop in Montgomery-AsbergDepression Rating Scale (“MADRS”).
These Phase 2 trial results are transformative for the Company as it takes its next steps into late-stage pharma” said Justin Hanka, Chief Executive Officer of MindBio Therapeutics.
MindBio has achieved a significant milestone as the only organization in the world that is running multiple clinical trials with Government and Regulatory approvals for take-home use and handling of a psychedelic medicine by trial patients out in the community, specifically a proprietary self-titratable form of Lysergic Acid Diethylamide (LSD) in microdoses designed for take home use (MB22001).
MindBio has collected tens of thousands of data points, over 3 years from clinical trials including psychometric data, speech analytics, sleep, biometric, activity data, EEG, ECG, PK/PD including DNA sampling.
MindBio is building a proprietary treatment model that is scalable, safe and effective and can be tailored to patients as a first line treatment for Depression.
Our proprietary drug candidate MB22001 is self-titratable, allowing patients to dose up or down depending on the individual’s tolerance.
The Phase 2a clinical trial demonstrated excellent safety, adherence and tolerance profile in doses tested.
This was consistent with the Phase 1 trial results.
We invite you to join us in support of creating a brighter future for mental health.
