This Week in Psychedelics

MindBio Therapeutics, Atai Life Sciences, and MindMed provide updates on their historic clinical trials and drug studies.

March 8, 2024

This Week...

MindBio Therapeutics received final approval for the world's first Phase 2B randomized controlled take home clinical trial microdosing MB22001(LSD) in patients with Major Depressive Disorder.

The trial has received Ethics approval, has been approved by the Clinical Trials Registry and received final ministerial approval to begin dosing, which will commence on 11 March 2024. Here’s more:

Atai Life Sciences announced that the first healthy participant has been dosed in its Phase 1b trial of VLS-01, an oral transmucosal film formulation of N,N-dimethyltryptamine (DMT).

The participants will initially receive a single dose of IV DMT followed by 3 different doses of VLS-01, with a 28-day washout window between administrations. Atai said that top-line results for the Phase 1b study are expected in the second half of this year. Check it out:

MindMed announced that the FDA has granted breakthrough designation to its MM120 (lysergide d-tartrate) program for the treatment of generalized anxiety disorder (GAD). The company also announced that its Phase 2b study of MM120 in GAD met its key secondary endpoint, and 12-week topline data demonstrated clinically and statistically significant durability of activity observed through Week 12.  The stock gained more than 50% on that news. Here’s more:

Did You Know?

Did you know that Japan’s Ainu people have a long history of psychedelic use? This ethnic group of related indigenous peoples native to northern Japan have a longstanding tradition of engaging with psychoactive mushrooms, which they actually consider to be sacred.

In their shamanic rituals, the Ainu consumed the mushrooms to induce altered states of consciousness, enabling communication with the spiritual realm and facilitating connections with deities and ancestors. It’s a fascinating history that you can read more about here: