MindBio Therapeutics Corp. is advancing its clinical trials of MB22001, a proprietary, titratable form of LSD for microdosing, as a potential treatment for Major Depressive Disorder and existential distress in late-stage cancer patients. The company's Chief Executive Officer, Justin Hanka, provided an update on the progress of two Phase 2 clinical trials, highlighting the potential of at-home LSD microdosing.
Phase 2a Trial in Major Depressive Disorder
The Phase 2a open-label trial is evaluating MB22001 in 20 patients diagnosed with Major Depressive Disorder. Participants self-administer titratable microdoses of the drug at home. As of the latest update, 19 out of the 20 participants have initiated their dosing regimen, and 8 have successfully completed the entire treatment protocol. The primary endpoint of the trial is the improvement in depression rating scores as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), a globally recognized standard for assessing depression severity. The company anticipates a readout of the Phase 2a depression trial in Q1.
Phase 2B Trial in Existential Distress
Concurrently, MindBio is conducting a Phase 2B randomized, double-blind trial involving 40 late-stage cancer patients experiencing existential distress. Existential distress is characterized by a combination of depressive, anxiety, and distress symptoms commonly observed at the end of life. The trial aims to assess the efficacy of MB22001 in alleviating these symptoms. If proven effective, MindBio hopes that MB22001 could become accessible to end-of-life patients through special drug access schemes, which allow access to experimental drugs before full regulatory approval.
Prior Clinical Evidence
MindBio's Phase 1 clinical trial, completed in 2022, demonstrated the safety and potential benefits of LSD microdosing. The trial reported no serious adverse events, and participants in the LSD-Microdosing treatment group experienced statistically significant improvements in feelings of happiness, social connectivity, wellness, creativity, and energy compared to the placebo group.
Company Perspective
"As we progress through these clinical trials, we inch closer to our commercialization objective that would see MB22001 used broadly, safely, with lower side effects, and more effectively for treating depression in the community," said Justin Hanka, Chief Executive Officer and Co-founder of MindBio Therapeutics.
