MindMed's Phase 3 Trials of MM120 for Generalized Anxiety Disorder Underway

MindMed has officially dosed the first patient in Panorama, its second phase 3 clinical trial evaluating MM120, a lysergide D-tartrate (LSD) treatment for generalized anxiety disorder (GAD).

The Voyage study, launched in late 2024, was the first-ever phase 3 trial of LSD for any condition. This trial focused solely on the U.S., with a two-arm design comparing a 100-microgram dose of MM120 against a placebo. The primary measure was the change in the Hamilton Anxiety Rating Scale (HAM-A) score at 12 weeks.

Now, Panorama expands on this research with a more comprehensive approach. Unlike Voyage, it includes both U.S. and European trial sites and introduces an additional dosing group—50 micrograms—alongside the 100-microgram and placebo groups. This additional dose helps to control for expectancy effects and strengthens the argument that MM120’s benefits are due to the drug itself rather than placebo effects.

“A lot of conversation has been had in this space about the role of functional blinding of participants having some awareness of what dosing group they're in, and how that might affect study results,” Karlin said. “And what we've done here between our phase 2 program, which had 5 dosing arms, and our phase 3 program, which have now 2 and 3 dosing arms, is to continue to build a strong argument for why, as we observe similar drug effects across these different studies, even as the placebo effect may vary due to things like functional and binding and expectancy, that we can make a strong argument for actual observed drug effect being that being the effect of the drug.”

Current anxiety treatments, mainly selective serotonin reuptake inhibitors and benzodiazepines, have limitations, including delayed onset and potential side effects. In contrast, MM120 has demonstrated rapid and long-lasting effects. phase 2 studies showed significant anxiety reduction as early as the day after a single dose, with benefits lasting up to 12 weeks. Researchers also observed a greater effect size compared to SSRIs, suggesting MM120 could offer a more potent and efficient alternative.

With Phase 3 trials underway, researchers aim to confirm the efficacy and safety of MM120 before seeking FDA approval. If successful, MM120 could revolutionize anxiety treatment, providing a new, fast-acting therapeutic option for patients.

Dr Karlin is the chief medical officer of MindMed and a fellow of the APA.