You are currently viewing Breakthrough Data, Black Box Sessions: A Closer Look at MindMed’s Phase 2b LSD for GAD Study

Breakthrough Data, Black Box Sessions: A Closer Look at MindMed’s Phase 2b LSD for GAD Study

Earlier this month, MindMed’s Phase 2b study of its lysergide D-tartrate candidate (dubbed MM120, which we also refer to simply as ‘LSD’ here) in adults with moderate to severe generalised anxiety disorder (GAD) was published in JAMA (Robison et al., 2025).

The study saw 198 patients receive a single dose of one of the following: 25 µg LSD, 50 µg LSD, 100 µg LSD, 200 µg LSD, or placebo. It took place at 22 outpatient psychiatric research sites across the U.S. from August 2022 to 2023.

MindMed shared topline results from the study in December 2023, and has since shared a trickle of additional data.

That initial readout reported that the trial met its primary endpoint, with a statistically significant, dose-dependent improvement in HAM-A scores at week 4 following the dosing session. Specifically, the company reported a HAM-A reduction in the 100 µg arm of 21.3 points, or 7.6 points over placebo, at week 4.

It also reported a 78% response rate in the 100 µg and 200 µg dose groups, and 50% remission at week 4 in the 100 µg arm. The drug, it said, was well tolerated.

A few months later, the company announced that it had received Breakthrough Therapy Designation from the FDA, and shared 12-week data.

Taken together with the publication of the study, the results are clearly positive, demonstrating a favourable efficacy and safety profile of the company’s LSD candidate. Indeed, MindMed was rewarded with a Breakthrough Therapy Designation and has since progressed to Phase 3 in both GAD and major depressive disorder (MDD).

While these headline findings were already disclosed, the study’s publication allows us to take a closer look at both the results but also the protocol and additional data…

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