MindBio Therapeutics Corp. has announced positive progress in its Phase 2B clinical trials investigating MB22001, a microdose formulation of lysergic acid diethylamide (LSD), for the treatment of major depressive disorder and end-of-life distress in advanced-stage cancer patients. An independent safety audit, conducted at the midpoint of both trials, revealed no serious adverse events or side effects, paving the way for continued patient recruitment and dosing.
Ongoing Phase 2B Trials
MindBio is currently conducting two Phase 2B trials:
- A triple-blind, double-dummy, active placebo-controlled trial in 90 patients with Major Depressive Disorder.
- A double-blind, placebo-controlled trial of MB22001 as an adjunct to Meaning Centred Psychotherapy in 40 patients with advanced-stage cancer experiencing end-of-life distress, anxiety, and depression.
These trials are unique as they are the only government-approved studies allowing patients to self-administer microdoses of a psychedelic medicine at home. The company utilizes proprietary technology to monitor medication adherence, detect potential diversion, and collect biophysical data from patients around the clock.
Safety and Tolerability
The positive outcome of the safety audit reinforces earlier findings from Phase 1 and Phase 2A trials, which indicated that MB22001 was well-tolerated with a low side effect profile compared to traditional antidepressants. Patients self-administer the drug in microdoses at home, allowing them to continue their daily activities without experiencing hallucinogenic effects.
"We are very pleased with the outcome of this mandatory independent safety audit of our clinical trials," said Justin Hanka, Chief Executive Officer of MindBio. "Whilst we won’t know the outcome of the trials until late 2025, this is a very good sign that side effects are not a problem with our lead candidate drug MB22001 and we can confidently continue our work."
Technological Advancements
In addition to the clinical trials, MindBio is leveraging machine learning and artificial intelligence to analyze the vast amounts of data collected, aiming to build precision diagnostic tools and identify genetic and physiological markers related to psychedelic medicine treatment. The company believes these technologies have the potential for broad commercialization beyond the pharmaceutical industry.
With patient recruitment and dosing resuming after a short holiday break, MindBio remains on track to complete the Phase 2B trials in late 2025. The company's innovative approach to psychedelic medicine, combined with its focus on safety and technological advancements, positions it as a leader in the development of novel treatments for mental health conditions.
