MindBio on Track to Finish Groundbreaking Phase 2a LSD Microdosing Trial for Depression

MindBio Therapeutics, a company at the forefront of developing innovative treatments for mental health conditions, is nearing the completion of its Phase 2a clinical trial. This trial involves the use of MB22001, a proprietary form of LSD designed for at-home microdosing, in patients suffering from Major Depressive Disorder (MDD). The final participant is expected to finish the trial around February 14, 2024, with preliminary results anticipated to be made public in March 2024.

Unique in the world, MindBio has regulatory approvals to conduct clinical trials with take-home microdoses of LSD (MB22001). Such approvals are pivotal for assessing the safety and efficacy of psychedelic substances in a community setting, as the company aims to secure global approval for these potentially life-saving treatments for severe mental health issues like depression. The Phase 1 trial of LSD-Microdosing, concluded in 2022, reported no serious adverse events and showed significant improvements in happiness, social connectivity, wellness, creativity, and energy among the treatment group compared to the placebo group.

The ongoing Phase 2a trial with 20 MDD patients is an open-label study focused on significant improvements in depression scores using the MADRS, a globally recognized scale for measuring depression severity. MB22001 is administered in adjustable microdoses, with the primary success criterion being an improvement in MADRS scores.

In addition to the Phase 2a trial, MindBio is also conducting a Phase 2B trial with late-stage cancer patients experiencing existential distress, a common end-of-life phenomenon characterized by depressive, anxiety, and distress symptoms. The company hopes that MB22001 will prove effective in this randomized, double-blind trial involving 40 participants, potentially making it available to end-of-life patients through special drug access programs before full regulatory approval.

MindBio's CEO and Co-founder, Justin Hanka, expressed enthusiasm for the upcoming trial completion and the advancement of the company towards later-stage pharmaceutical drug development, aiming to provide better treatments for mental health conditions.

MindBio Therapeutics is dedicated to pioneering new and emerging treatments for mental health, leading the way in microdosing psychedelic medicines through clinical trials. The company has developed a multidisciplinary platform for treatment development, encompassing psychedelic medicine and digital therapeutics. It has completed Phase 1 clinical trials involving 80 patients and is currently conducting Phase 2 trials for MDD and late-stage cancer patients experiencing existential distress. MindBio's research is foundational in developing novel and clinically proven treatments, including digital technologies and interventions for conditions such as depression, anxiety, and related mental health issues.