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MindMed's MM120 Shows Promise in Phase 2b Trial for Generalized Anxiety Disorder

• MindMed's MM120, a lysergide d-tartrate (LSD) formulation, demonstrates rapid and durable improvement in patients with generalized anxiety disorder (GAD) after a single dose in Phase 2b trial. • The Phase 2b study results have prompted the initiation of Phase 3 trials, incorporating randomized, double-blind, placebo-controlled designs to validate the efficacy and safety of MM120. • Clinicians express cautious optimism regarding MM120's potential, acknowledging the need for robust Phase 3 evidence to confirm its clinical benefits and address existing skepticism. • If approved, MM120 could offer a novel pharmacological intervention for GAD, providing rapid and sustained relief without daily administration, addressing a significant unmet need.

MindMed's MM120, a formulation of lysergide d-tartrate (LSD), is showing promise as a potential treatment for generalized anxiety disorder (GAD). Phase 2b trial results indicate that a single dose of MM120 can lead to rapid and durable improvements in patients, sparking interest and cautious optimism within the psychiatric community.

Promising Phase 2b Data

Daniel R. Karlin, MD, MA, chief medical officer of MindMed, noted the initial interest in LSD for treating psychiatric illness. The drug was not utilized after being categorized as a Schedule I substance. "Certainly it is reasonable to think that some people used them because they believe that they were sustaining the sorts of benefits we are able to now see in clinical research," Karlin stated. The Phase 2b study revealed that patients receiving a higher dose of MM120 experienced rapid improvement after just one dose.

Addressing Skepticism and Moving to Phase 3

Recognizing the skepticism among clinicians due to limited advancements in GAD treatment, Karlin emphasized the need for rigorous Phase 3 trials. "We are saying that we are seeing highly promising phase 2 data, we are running the best phase 3 program we possibly can to try to generate the evidence that will convince the skeptics that what we are seeing is real drug effect that will translate out into real clinical practice," Karlin explained.
The Phase 3 program consists of two periods: an initial 12-week randomized, double-blind, placebo-controlled phase, followed by a 40-week extension period where participants can receive open-label MM120 treatment based on symptom severity. This design aims to thoroughly evaluate both the short-term and long-term effects of the drug.

Potential Impact on GAD Treatment

If approved, MM120 could represent a significant advancement in GAD treatment. Its potential to provide rapid and sustained improvement with a single dose, rather than daily medication, could greatly improve patient compliance and quality of life. The ongoing Phase 3 trials are crucial in confirming these promising early results and establishing MM120's role in future psychiatric practice.
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Reference News

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Where do Psychedelics Fit in the Future of Psychiatry? - Psychiatric Times
psychiatrictimes.com · Dec 24, 2024

Daniel R. Karlin, MD, MA, discusses the potential of psychedelics like LSD in psychopharmacology, noting rapid and durab...

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