MindBio Therapeutics Completes Dosing in Landmark Take-Home Phase 2B Microdosing Depression Trial

Executive Summary

• MindBio Therapeutics announced that dosing in its landmark Phase 2B trial of MB22001 for Major Depressive Disorder has been completed across 90 patients.
• The trial is a triple‑blind, double‑dummy, active‑placebo‑controlled study and the results are expected shortly, potentially paving the way for post‑Phase 2B commercialisation and Phase 3 trials.
• Successful outcomes would position MindBio as the first company with regulatory approval for take‑home microdose psychedelic therapy in late‑stage clinical testing.

Key Details

• Trial Design: Triple‑blind, double‑dummy, active placebo‑controlled; 90 patients with Major Depressive Disorder (MDD).
• Candidate: MB22001 – a titratable microdose formulation of LSD intended for safe take‑home use (sub‑hallucinogenic doses).
• Regulatory Milestone: First psychedelic medicine to receive regulatory approval for take‑home administration in clinical trials.
• Current Status: Dosing phase completed; data analysis underway with results expected “shortly.”
• Future Pathway: Positive data could enable early and special access programs worldwide and support initiation of Phase 3 studies.
• CEO Quote: Justin Hanka (CEO) described the dosing completion as a “pivotal moment” toward commercialisation of novel psychiatric treatments.

Notable Quotes

“This is a pivotal moment for MindBio as we progress the development of novel treatments for psychiatric conditions towards commercialization. We look forward to presenting the results of this important clinical trial which is expected shortly.” – Justin Hanka, Chief Executive Officer