Pharma Focus Europe

Mindbio Therapeutics Initiates Pre-screening of Participants for Groundbreaking Phase 2 Trial: Evaluating Home-based Lsd-microdosing in Major Depressive Disorder Patients

Thursday, July 20, 2023

MindBio Therapeutics Corp. (CSE:MBIO)(Frankfurt:WF6) has recently initiated the pre-screening process for participants in Phase 2 LSD-Microdosing clinical trials, signifying a significant step forward for the company. Notably, these trials have gained approvals for the take-home use of MindBio's LSD-Microdosing treatment. The primary focus of the Phase 2a trial will be to examine the treatment's efficacy in patients suffering from Major Depressive Disorder during an 8-week period.

The initial findings from MindBio's earlier LSD-Microdosing clinical trials have been encouraging, indicating positive outcomes in various aspects, such as improvements in sleep quality (including REM and total sleep time) and statistically significant enhancements in subjective feelings of well-being, creativity, happiness, social connectivity, and energy. Moreover, participants receiving LSD-Microdosing reported statistically significant reductions in feelings of anger and irritability, suggesting potential mental health benefits.

MindBio's accomplishments in developing exclusive formulations for microdosing and secure delivery solutions have facilitated the approval for take-home use in clinical trials, granting the company a unique global first mover advantage. Their strategic focus on big data involves leveraging the data collected during the trials to enhance their intellectual property and pave the way for the commercialization of microdosing treatments. This includes providing a package of proprietary solutions for safe and effective at-home administration of psychedelics.

As the only organization worldwide approved for take-home use of LSD-Microdosing in clinical trials, MindBio is well-positioned to address global regulatory requirements while advancing their commercialization strategy. Justin Hanka, the Co-founder and CEO, expressed enthusiasm for the progress of LSD-Microdosing protocols to Phase 2 trials, especially for targeting patients with Major Depressive Disorder and related mood and sleep disturbances.

MindBio's investment focus centers around creating a scalable, safe, accessible, and affordable treatment model using microdosing, with the intention of addressing the challenges in mental health care. Additionally, their approach accommodates the diverse medical regulatory regimes across different regions, making it an attractive prospect for global implementation.

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