Mind Medicine (MindMed) has reported positive topline data from its Phase IIb clinical trial of MM-120 (lysergide d-tartrate) for the treatment of generalised anxiety disorder (GAD).
The double-blind, parallel, multicentre, randomised, dose-optimisation, placebo-controlled trial enrolled 198 subjects. These participants were randomised to receive a single dose of 25µg, 50µg, 100µg or 200µg of the therapy or placebo.
Determining the dose-response relationship of the four treatment doses versus placebo from baseline to week four was the trial’s primary objective.
Assessments of anxiety symptoms, safety, tolerability efficacy and quality of life comprised secondary objectives.
MM-120 offered meaningful dose-based improvements on the Hamilton Anxiety rating scale (HAM-A) versus placebo, meeting the primary endpoint.
In the trial, a 100µg dose achieved the maximum clinical activity demonstrating a 7.6-point decline versus placebo at week four.
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Furthermore, 78% of subjects who received 100 or 200µg MM-120 attained clinical response versus 31% for placebo.
MM-120 was found to be well tolerated with hallucinations, illusion, euphoric mood, anxiety and headache among others to be the most frequently seen adverse events.
The company intends to hold an End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) in the first half of next year.
A Phase III clinical programme is anticipated to be launched in the second half.
MindMed CEO and director Robert Barrow said: “We are excited by the strong positive results for MM-120 in GAD, particularly given that this is the first study to assess the standalone drug effects of MM-120 in the absence of any psychotherapeutic intervention.
“These promising findings represent a major step forward in our goal to bring a paradigm-shifting treatment to the millions of patients who are profoundly impacted by GAD.
“We look forward to sharing additional study results in the coming months – including topline 12-week results in the first quarter of 2024 – and working closely with FDA as we finalise the Phase III development programme for MM-120 in GAD.”