First Patient Dosed in Second Phase 3 Study of Psychedelic MM120 for Generalized Anxiety Disorder

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MindMed has dosed the first patient in its second phase 3 trial evaluating lysergide D-tartrate (LSD) as a treatment for generalized anxiety disorder (GAD). In December, the company announced the first patient had been dosed in Voyage, its first ever phase 3 trial for MM120 orally disintegrating tablet (ODT).

Panorama introduces a 50 µg dosing arm to the study design, designed to mitigate functional unblinding bias and enhance the reliability of results.¹ This sets it apart from Voyage, which tested a 100 µg dose against placebo.² In an interview with MindMed’s chief medical officer, Daniel R, Karlin, MD, MA, he said, “That 50 microgram dose group exists to confound the understanding of folks in the active arm, the 100 microgram arm and in the placebo arm, as to what they received, and to create that uncertainty in those groups, sort of further reinforce our understanding of measured drug effect being actual drug effect.”

The trial will enroll approximately 250 participants across the US and Europe, and builds on positive phase 2b data presented at the American Psychiatric Association Annual Meeting in May 2024. It will begin with a 12-week double-blind period with a 40-week extension period, where participants may receive open-label treatment based on symptom severity. The primary endpoint will measure the change from baseline in the Hamilton Anxiety Rating Scale score at week 12.¹

MM120 ODT, using Catalent’s Zydis ODT fast-dissolve technology, received Breakthrough Therapy Designation from the US Food and Drug Administration and offers rapid absorption, improved bioavailability, and fewer gastrointestinal adverse effects.¹ In its phase 2b study, MM120 demonstrated rapid and sustained clinical response, with 65% of participants showing improvement and 48% achieving clinical remission at 12 weeks.¹

In regards to phase 2, Karlin said, “We tested 25, 50, 102, 100 micrograms against placebo, and discovered definitively that 100 micrograms was the dose that we wanted to bring forward because of its efficacy and its side effect profile versus the other dosing arms.”

GAD treatment options—including benzodiazepines, buspirone, and selective serotonin reuptake inhibitors—often require daily use, multiple medication switches, and may not be effective for all patients. The last FDA-approved treatment for GAD dates back to 1987, highlighting a need for innovation.¹ In a press release, Karlin said, “MM120 ODT represents a potentially life-changing treatment for people living with GAD, and if our phase 3 development program is successful, it could offer a differentiated and compelling option for one of the most significant unmet needs in psychiatry. We aspire to deliver a truly transformational treatment that we believe has the potential to change the trajectory of the ongoing brain health epidemic.”¹

Psychiatric Times spoke with Daniel R. Karlin, MD, MA, in an exclusive video.

1. MindMed announces first patient dosed in panorama, the second pivotal phase 3 study of MM120 in generalized anxiety disorder. Business Wire. January 30, 2025. Accessed February 7, 2025. https://www.businesswire.com/news/home/20250127889062/en/

2. McSweeney M. First patient dosed in phase 3 study of psychedelic mm120 in generalized anxiety disorder. Psychiatric Times. December 17, 2024. https://www.psychiatrictimes.com/view/first-patient-dosed-in-phase-3-study-of-psychedelic-mm120-in-generalized-anxiety-disorder