Mind Medicine has confirmed it has completed enrollment of Study MMED007, its Phase 2a study evaluating repeated low-dose administration of MM-120 (LSD) for the treatment of adults with ADHD.
The trial is a multi-center, randomised, double-blind, placebo-controlled Phase 2a study of MM-120 (20 μg) compared with a placebo. The company explains that 20 μg is about 20% of the dose typically consumed for recreational psychedelic purposes.
MindMed has stated it is developing MM-120, a tartrate salt form of lysergide, for generalised anxiety disorder (GAD) and ADHD.
The treatment will be administered orally twice weekly for six weeks in patients between the ages of 18 and 65 with ADHD, with 26 receiving MM-120 and 26 receiving the placebo.
CEO and Director of MindMed, Robert Barrow, commented: “We are pleased to announce the completion of enrollment of our Phase 2a study in adults with ADHD.
“This proof-of-concept trial is designed to evaluate the clinical effects of a sub-perceptual dose of MM-120 administered in a repeated fashion.
“The study’s results will inform our ongoing work to establish new clinical paradigms for this promising drug candidate. We anticipate sharing topline data by the end of the first quarter of 2024.”
Mind Medicine has stated that the primary endpoint of the study is mean change from Baseline in ADHD symptoms, as assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS) after six weeks of treatment.
Key secondary objectives include assessments of ADHD symptom severity, as well as safety and tolerability, and will be measured up to 10 weeks after the initial dose.
