Mind Medicine has concluded the enrolment of 198 patients and dosing in the Phase IIb MMED008 clinical trial of MM-120 (lysergide D-tartrate) to treat generalised anxiety disorder (GAD).

The dose-optimisation, parallel, multi-centre, placebo-controlled, double-blind, randomised study is designed to compare the effect of different dosages of MM-120 against placebo in GAD patients.

Subjects aged 18 to 75 years with anxiety symptoms are included in the study.

They will be randomised to receive a single dose of 25µg, 50µg, 100µg or 200µg of MM-120, or placebo.

The primary goal of the study is to determine the dose-response relationship of four MM-120 doses compared with placebo.

It will be measured by the change in Hamilton Anxiety Rating Scale (HAM-A) from baseline to week four.

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By GlobalData

Key secondary objectives include assessments of tolerability, safety, anxiety symptoms, quality of life, and other measures of efficacy.

These assessments are measured up to 12 weeks after the single administration of MM-120.

Mind Medicine CEO and director Robert Barrow said: “Completion of enrolment of this study is a significant milestone for MindMed and moves us one step closer to our goal of transforming the treatment of GAD for the millions suffering from the disorder.

“Thanks in large part to the enthusiasm we have seen regarding MM-120 among investigators and patients, as well as the strong execution of our team, we were able to enrol almost 200 participants in this trial in just over a year.

“We anticipate sharing topline results during the fourth quarter of this year.”