Hi

MindBio is pleased to report that dosing is progressing well in its Phase 2a Depression trial using MB22001 (MindBio’s proprietary titratable form of LSD for take-home Microdosing). The final participant in this landmark clinical trial is nearing completion and is expected to complete dosing on about 14 February 2024. Top line results from the Phase 2a Depression trial are expected to be announced to the market some-time in March 2024. 

MindBio is the only company in the world to be running clinical trials with regulatory approvals for take-home use of a special form of LSD in microdoses (MB22001).  Take home approvals in these trials is crucial for testing and modeling the safety and efficacy of psychedelics within the community, as MindBio works towards having these life-saving medicines globally approved for use in treating debilitating mental health conditions such as Depression. MindBio’s landmark Phase 1 LSD-Microdosing clinical trial completed in 2022 showed no serious adverse events, and participants in the treatment group reported statistically significant increases in feelings of happiness, social connectivity, wellness, creativity, and energy compared to the placebo group.  

MindBio’s Phase 2a clinical trial in 20 patients with Major Depressive Disorder is an open label trial that will look for clinically significant improvements in depression rating scores using a global standard for measuring the severity of depression, the MADRS (Montgomery Asberg Depression Rating Scale). MB22001 is being administered in titratable microdoses to clinical trial participants. At the end of the trials, the primary end point for success is an improvement in the MADRS.

Concurrently, MindBio is 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 and anxiety and distress symptoms that often is treated with anti-depressants. MindBio’s hope is that MB22001, if proven effective in this Phase 2B randomized and double blind trial in 40 participants, will potentially be accessible to end of life patients under special drug access schemes that permit access to clinical stage experimental drugs before they are approved by regulatory bodies such as the Food & Drug Administration (FDA).

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

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Stay Well!

Justin Hanka, Co-Founder and Chief Executive Officer