MindBio Therapeutics is nearing the completion of its Phase IIa study investigating MB22001, a titratable form of lysergic acid diethylamide (LSD), in major depressive disorder patients.

The final participant is anticipated to finish dosing on 14 February 2024, with top-line results expected in March 2024.

MindBio said that it is the only company to have regulatory approval for the use of take-home microdoses of LSD.

The take-home aspect is vital for evaluating the safety and efficacy of psychedelics in a community setting.

MindBio aims to secure global approval for these potential treatments for severe mental health conditions, such as depression.

The Phase IIa trial involves 20 patients and is an open-label study focusing on clinically significant improvements in depression scores, as measured by the Montgomery Asberg Depression Rating Scale (MADRS).

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Participants are receiving MB22001 in microdoses, with the primary endpoint being an improvement in MADRS scores.

In 2022, MindBio completed a Phase I LSD microdosing trial, which reported no serious adverse events. Participants experienced notable increases in happiness, social connectivity, creativity, wellness, and energy compared to those in the placebo group.

Alongside the Phase IIa trial, MindBio is conducting a Phase IIb trial with 40 late-stage cancer patients suffering from existential distress.

This trial is randomised and double-blind, and if MB22001 proves effective, it could become accessible to end-of-life patients through special drug access schemes before full regulatory approval.

MindBio CEO and co-founder Justin Hanka said: “We are looking forward to the completion of this landmark clinical trial and progressing the business towards late-stage pharma drug development and commercially advancing better treatments for mental health conditions.”