MindMed begins phase 3 study of MM120 for anxiety disorder

First patient dosed in landmark trial for GAD treatment

MindMed has announced the dosing of the first patient in its phase 3 Voyage study of MM120 ODT, a pharmaceutically optimised form of lysergide D-tartrate (LSD) for treating Generalised Anxiety Disorder (GAD).

The study aims to evaluate the efficacy and safety of MM120 ODT compared to placebo, with approximately 200 participants expected to enrol in the United States.

“Today marks a pivotal moment in our journey towards advancing a novel treatment option for the 20 million people in the US living with GAD,” said Dr Daniel R. Karlin, Chief Medical Officer of MindMed.

He emphasised that the phase 3 studies are built on rigorous phase 2b results, which showed efficacy exceeding current standards of care and a favourable tolerability profile.

The 52-week Voyage study consists of two parts: a 12-week randomised, double-blind, placebo-controlled period, followed by a 40-week extension with open-label treatment based on symptom severity.

The primary endpoint will measure the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) at Week 12, consistent with the phase 2b study’s observed durable clinical effect.

“It is critical to continue to develop new and effective treatment options for patients with GAD, a debilitating condition where there is an urgent need for transformational innovation,” said Dr David Feifel, an investigator in the Voyage study.

The study design includes best-in-class methodologies to mitigate unblinding and isolate the standalone drug effect of MM120 ODT.

GAD affects around 20 million adults in the US, causing significant personal and societal burdens. Despite this, there has been little innovation in treatment over the past decades.

MindMed’s MM120 ODT offers a novel approach, leveraging rapid absorption and improved bioavailability to enhance therapeutic outcomes.

Based on significant unmet medical needs and promising phase 2b results, the U.S. FDA has granted Breakthrough Therapy Designation for the MM120 programme in GAD.

MindMed plans to expand its clinical development program with the Panorama study in the US and Europe, starting in the first half of 2025.