- MindBio Therapeutics (CSE:MBO) secured regulatory and ministerial approvals for MB22001 to be self-administered by patients
- The team behind the psychedelic stock has begun the first dosing in a Phase 2B randomized controlled clinical trial microdosing MB22001 in patients with major depressive disorder
- In this trial, patients with major depressive disorder will undertake an eight-week regimen of MindBio’s lead candidate drug, MB22001, a proprietary titratable and self-administered form of lysergic acid diethylamide for at-home use
- MindBio Therapeutics last traded at $0.060 per share
MindBio Therapeutics (CSE:MBIO) secured regulatory and ministerial approvals for MB22001 – a form of LSD – to be self-administered by patients.
The team behind the psychedelic stock has begun the first dosing in a Phase 2B randomized controlled clinical trial microdosing MB22001 in patients with major depressive disorder.
In this Phase 2B randomized, triple blind and active placebo-controlled trial, patients with major depressive disorder will undertake an eight-week regimen of MindBio’s lead candidate drug, MB22001, a proprietary titratable and self-administered form of lysergic acid diethylamide (LSD) designed for use at home.
After the eight-week trial, placebo and drug group participants will be invited to participate in an eight-week open-label extension to ensure the placebo group has the opportunity to experience treatment with MB22001, potentially resulting in 16 weeks of data being collected from every patient.
The company believes that small, sub-hallucinogenic doses of MB22001 is the most scalable way to use a psychedelic medicine to treat depressive disorders globally. The goal is to commercialize MB22001 as an affordable, accessible replacement to first-line medications such as anti-depressants – with low side effects. MindBio pointed out this was especially the case with no sexual side effects, emotional numbness or weight gain, which could result in greater adherence to the treatment.
Last month, the company completed its Phase 2a trial in patients with major depressive disorder and found they experienced a 60 per cent drop in depressive symptoms. Fifty-three per cent of patients entering the trial with MDD, at the eighth-week mark, were in complete remission from their depression marked by an impressive mean 14.1-point drop in Montgomery-Asberg Depression Rating Scale score. Prior trial results using MB22001 recorded statistically significant improvements in sleep quality and increases in subjective feelings of happiness or energy.
“Microdosing MB22001 is a disruptive treatment methodology using psychedelic medicines and our ambition is to develop this treatment globally at scale for affordable access to patients without the limitations and side-effects of common anti-depressants,” Justin Hanka, MindBio’s chief executive officer, said in a statement.
MindBio Therapeutics is a biotech and biopharmaceutical company developing treatments for mental health conditions.
MindBio Therapeutics (CSE:MBIO) last traded at $0.060 per share.
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