MindBio Therapeutics Corp. announced first dosing has begun in a Phase 2B randomised controlled clinical trial microdosing MB22001 in patients with Major Depressive Disorder. In a world first series of clinical trials, MindBio has secured regulatory and ministerial approvals for MB22001 to be self-administered by participants out in the community and at home.
In this Phase 2B randomised, triple blind and active placebo-controlled trial, patients with major depressive disorder (MDD) will undertake an 8 week regimen of MindBio’s lead candidate drug, MB22001, a proprietary titratable and self-administered form of Lysergic Acid Diethylamide (LSD) designed for take-home use. In this trial (n=90) half the participants will take an active placebo and the other half will take MB22001. After the 8 week trial, both placebo and drug group participants will be invited to participate in an 8 week open-label extension to ensure the placebo group has the opportunity to experience treatment with MB22001 resulting in potentially 16 weeks of data being collected from every patient.
MindBio’s unique investment thesis in the sector, is that small, sub-hallucinogenic doses of a psychedelic drug, MB22001 is the most scalable way to use a psychedelic medicine to treat depressive disorders globally. The Company’s goal is to commercialize MB22001 as an affordable, accessible replacement to first line medications such as anti-depressants with low side effects (particularly no sexual side effects, emotional numbness, or weight gain) resulting in greater adherence to the treatment. In February 2024, MindBio completed its Phase 2a trial in patients with Major Depressive Disorder.
In this open label trial, patients experienced a 60% drop in depressive symptoms and 53% of patients entering the trial with MDD, at week 8 were in complete remission from their depression marked by an impressive mean 14.1 point drop in MADRS score (Montgomery-Asberg Depression Rating Scale). Prior trial results using MB22001 recorded statistically significant improvements in sleep quality and increases in subjective feelings of “Happiness”, “Social Connectivity”, “Energy”, “Creativity” and “Wellness” with reduced “Anger” and “Irritability”. MB22001 is a promising and potential market disruptive medicine for treating depressive illness.