Mind Medicine (MindMed) has enrolled and dosed more than 50% participants in its Phase IIb trial of MM-120 (lysergide D-tartrate) to treat generalised anxiety disorder (GAD).
The double-blind, multi-centre, dose-optimisation, placebo-controlled, parallel, randomised trial has been designed for evaluating four MM-120 doses to treat anxiety symptoms in GAD diagnosed patients.
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Up to 200 participants are planned to be enrolled in the trial. They will receive a single administration of 25µg, 50µg, 100µg or 200µg MM-120 doses or placebo.
The determination of reduction in anxiety symptoms four weeks after single MM-120 administration compared across the five treatment arms is the trial’s primary objective.
Evaluation of tolerability, safety, and anxiety symptoms along with other measures of quality of life and efficacy that are measured up to 12 weeks after a single administration, are the important secondary objectives of the trial.
The company expects to obtain topline data from the trial later this year.
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By GlobalDataMindMed director and CEO Robert Barrow said: “We are thrilled by the quality and efficiency with which study enrolment has progressed as we approach our expected top-line data release later this year.
“This progress is a testament to the tireless work and dedication of all the individuals executing this study and stands out as one of the fastest recruiting efforts for this class of therapies in development.
“We have seen a meaningful acceleration in enrolment over the last few months since our full set of study sites were activated early this year with 25 patients enrolled just in the last 30 days.”
