Evaluating MM120 for GAD with Daniel Karlin, MD, and Reid Robinson, MD, MBA

A couple of months ago on March 7, 2024, MindMed announced the US Food and Drug Administration (FDA) granted them a breakthrough therapy designation for MM120 (lysergide d-tartrate) for generalized anxiety disorder (GAD) after a phase 2B trial met its secondary endpoint.¹

The findings demonstrated a single oral administration of MM120, 100 ug, in GAD had clinical and significant durability through week 12. MindMed already announced back in December they met their primary endpoint: MM120 providing significant and clinically meaningful improvements in GAD after 4 weeks, demonstrated by the change in the Hamilton Anxiety Rating Scale from baseline.²

Daniel Karlin, the chief officer at MindMed, presented data on the complete phase 2b, placebo-controlled, double-blind study on MM-120 for GAD at the annual American Psychiatric Association (APA) conference in New York.³ He said MM-120 provided a rapid response, with responses as early as the day following the dose.

“Most notably, 50% of patients were in remission from their GAD at week 4,” Karlin told HCPLive. “and that number stayed really similar out to week 12 [with] 48% of patients remaining in remission through Week 12.”

The study evaluated MM120 at doses 25, 50, 100, and 120 mg with a baseline Hamilton Anxiety Score of 30.

“An interesting thing about the study is that it also let individuals in with high depression scores,” Reid Robinson, MD, MBA, the principal investigator at Numinus, told HCPLive.

The results showed MM120 meaningfully reduced participants’ depression symptoms along with their depression symptoms.

“[This] is exciting because we know as clinicians that there's a lot of overlap between anxiety disorders and depressive symptoms,” Robinson said. “And so, this may represent a potential treatment option in the future.”

Along with MM120, other psychedelic drugs like MDMA-assisted therapy and psilocybin for major depressive disorder and treatment-resistant depression, have been given a fast-track designation by the FDA.

“It’s an exciting time for psychiatry where we have these new and novel potential treatment options that are getting to this pivotal point of going up for potential approval,” Robinson said. “So, the future is bright in my opinion; it's an exciting time to be in psychiatry, where we, and our patients especially, desperately need new treatment options, especially those that will work quicker and have a good safety and efficacy.”

References

1. ^{Derman, C. Daniel Karlin, MD: FDA Grants Breakthrough Designation to MM120 for Anxiety. HCPLive. March 13, 2024. https://www.hcplive.com/view/daniel-karlin-md-fda-grants-breakthrough-designation-to-mm120-for-anxiety. Accessed May 8, 2024.}
2. ^{Derman, C. Daniel Karlin, MD: Topline MM-120 Data for Generalized Anxiety Disorder. HCPLive. December 15, 2023. https://www.hcplive.com/view/daniel-karlin-md-topline-data-mm-120-generalized-anxiety-disorder. Accessed May 8, 2024.}
3. ^{Karlin, D. Rapid and Durable Response to a Single Dose of MM120 (Lysergide) in Generalized Anxiety Disorder: A Dose-Optimization Study.” Poster presented at: American Psychiatric Association (APA) 2024 Annual Meeting. New York, NY. May 4 – 8, 2024.}