MindBio Therapeutics Initiated MB22001 Phase 2 Clinical Trial of LSD Microdosing

MindBio Therapeutics (CSE:MBIO) (FSE:WF6), a Melbourne, Australia-based biotech/biopharma company creating novel and emerging treatments for mental health conditions, has initiated dosing of MB22001 to patients in a landmark microdosing study for depression.

This groundbreaking trial represents a global precedent and stands as the sole clinical trial authorized for the take-home usage of LSD.

MB22001, an innovative, titratable form of Lysergic Acid Diethylamide (LSD) developed by MindBio, is tailored for safe and efficacious at-home microdosing in patients grappling with Major Depressive Disorder.

Administered at sub-hallucinogenic levels, this therapeutic microdose is taken every third day over an 8-week span in an open-label Phase 2a clinical trial involving 20 participants.

The primary objective of this Phase 2a trial is to assess the feasibility, tolerability, and effectiveness of MB22001 microdosing in individuals with Major Depressive Disorder.

The outcomes of this study will lay the foundation for the progression into a significantly larger Phase 2b trial, designed as a randomized, triple-dummy controlled investigation in patients with depression.

Notably, MindBio's prior clinical evaluations of MB22001 have already yielded encouraging topline data in healthy volunteers.

The results of the Phase 1 randomized controlled trial involving 80 healthy participants revealed unexpected sleep data from a cumulative 3200 days of sleep monitoring, indicating an average increase of 24 minutes in total sleep time and an additional 8 minutes of REM sleep the day after dosing.

This landmark trial further demonstrated statistically significant enhancements in self-reported feelings of "wellness," "creativity," "happiness," "social connectivity," and "energy" on dosing days.

Participants receiving MB22001 microdoses also reported substantial reductions in feelings of "anger" and "irritability," with statistical significance.

Envisioning the commercialization of microdosing treatments, MindBio is committed to delivering a suite of proprietary solutions tailored for the safe and effective utilization of psychedelics at home.

The distinction of being the sole entity globally sanctioned for the take-home use of LSD microdosing in clinical trials is pivotal for validating the real-world applicability of MindBio's proprietary solutions, as the company advances its commercialization strategy aimed at securing global regulatory endorsements.

Justin Hanka, CEO, stated: "We are delighted to begin this important clinical trial in patients suffering from the debilitating effects of depression and we hope that this medicine and unique treatment protocol will be effective at mitigating those symptoms and provide a superior treatment outcome to the current available treatment options for depression".

MindBio's strategic focus on microdosing revolves around establishing a unique treatment model characterized by global scalability, safety, accessibility, and affordability.

This approach aims to address the existing complexities in mental health care while accommodating the diversity of medical regulatory frameworks worldwide.

A second Phase 2 trial is currently focusing on microdosing LSD in late-stage cancer patients facing existential distress.

MindBio's commitment extends to investing in research forming the basis for clinically proven, novel treatments, including digital interventions, aimed at debilitating health conditions such as depression, anxiety, and related mental health issues.

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