MindBio Therapeutics Announces Completion of Groundbreaking Phase 2a LSD Microdose Trial

LOS ANGELES- In a significant advancement for psychiatric medicine, MindBio Therapeutics Corp., a pioneering biopharmaceutical company, has announced the successful completion of its Phase 2a clinical trial, marking a pivotal moment in the development of treatments for Major Depressive Disorder (MDD). This trial is notably the world’s first to receive regulatory approval for the take-home use of a psychedelic medicine, specifically a titratable form of Lysergic Acid Diethylamide (LSD) known as MB22001, designed for microdosing.

The open-label trial aimed to identify clinically significant changes in depression severity, utilizing the globally recognized Montgomery Asberg Depression Rating Scale (MADRS). The primary endpoint for MB22001’s success in treating depression was marked by improvements in MADRS scores, following its administration in carefully titrated microdoses to participants suffering from MDD.

Justin Hanka, CEO and Co-founder of MindBio, expressed the company’s excitement over this milestone, highlighting the potential of MB22001 to revolutionize the treatment landscape for psychiatric conditions. “This is a pivotal moment for MindBio as we progress the development of novel treatments for psychiatric conditions,” Hanka stated. The company is currently analyzing the extensive data collected from the trial and anticipates sharing the results in the upcoming weeks.

Parallel to this achievement, MindBio is conducting a Phase 2B trial targeting late-stage cancer patients experiencing existential distress, a condition often managed with antidepressants, characterized by a mix of depressive, anxiety, and distress symptoms common in end-of-life scenarios.

The success of MindBio’s Phase 2a trial builds on the positive outcomes of its comprehensive Phase 1 trial, which involved 80 healthy individuals and demonstrated MB22001’s safety, tolerance, and statistically significant improvements in mood. Notably, the trial also uncovered significant enhancements in sleep quality, including REM sleep time, total sleep time, and overall sleep quality observed the day following each dose.

MindBio’s achievements represent a major leap forward in the integration of psychedelic medicines into mainstream psychiatric treatment, promising a future where conditions like Major Depressive Disorder can be addressed more effectively and compassionately. With the world watching, MindBio Therapeutics is at the forefront of redefining mental health treatment paradigms, ushering in a new era of hope and healing for patients worldwide.