Mind Medicine (MindMed) has dosed the first subject in its Phase IIb clinical trial of MM-120 to treat generalised anxiety disorder (GAD), a chronic mental health disorder.
A total of 200 GAD subjects will be enrolled in the dose-optimisation, multicentre, parallel, double-blind, randomised, placebo-controlled trial of MM-120.
These subjects will be given either a single dose of up to 200µg MM-120 or a placebo.
The decline in anxiety symptoms four weeks following administration of a single dose of MM-120, compared across the five treatment cohorts, will be the trial’s primary objective.
Evaluating the safety, tolerability, and quality of life, measured up to 12 weeks following dosing, will be the key secondary objectives of the trial.
Based on the results from this trial, the dose selection and development strategy for the Phase III clinical trials will be carried out to make a new potential therapy for GAD patients available.
MM-120 is a pharmaceutically enhanced form of lysergic acid diethylamide (LSD).
MindMed CEO and director Robert Barrow said: “The initiation of our Phase IIb clinical trial, the largest well-controlled clinical trial of LSD ever conducted, represents a major milestone for MindMed and for the many patients suffering from GAD.
“This exciting next step in the advancement of LSD builds on the positive topline data presented by our partners at University Hospital Basel in May 2022, which demonstrated the rapid, durable, and statistically significant effects of LSD and its potential to safely mitigate symptoms of anxiety and depression.”
As per the National Institute of Mental Health (NIMH), the GAD symptoms comprise excessive anxiety and worry that last for more than six months.
These symptoms can cause substantial impairments in social, occupational, and other functioning.