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Mind Medicine (MindMed) has dosed the first subject in the Phase III Panorama study of a proprietary form of lysergide D-tartrate (LSD), MM120 orally disintegrating tablets (ODT), for the treatment of generalised anxiety disorder (GAD).
The 52-week trial will take place across Europe and the US, aiming to enrol approximately 250 subjects.
Part A of the trial consists of a 12-week, parallel-group, placebo-controlled, double-blind period, followed by a Part B 40-week open-label extension period.
In Part B, the subjects will be qualified for open-label treatment with the tablet, depending on the severity of their symptoms.
Subjects in the trial will receive either a 100µg or 50µg dosage or a placebo, with the 50µg group designed to prevent patients from accurately identifying the dose they were given.
This strategy is in line with the US Food and Drug Administration’s (FDA) guidance and follows the MM120 Phase IIb study’s findings, which suggested that the clinical activity of MM120 was not due to functional unblinding.
The trial’s primary endpoint will be the changes from baseline in the Hamilton Anxiety Rating Scale (HAM-A) at week 12 with the 100µg dosage of the tablet, compared to the placebo.
This follows the positive indications from the Phase IIb study regarding MM120’s durable clinical effect.
MindMed chief medical officer Dan Karlin said: “This is an incredible time for MindMed, and we are optimistic about what lies ahead as we embark on our second Phase III study for MM120 ODT in GAD only weeks after the successful launch of our first Phase III study, Voyage.
“MM120 ODT represents a potentially life-changing treatment for people living with GAD, and if our Phase III development programme is successful, it could offer a differentiated and compelling option for one of the most significant unmet needs in psychiatry.”
MM120 ODT leverages Catalent’s Zydis ODT technology, known for its quick absorption and ‘improved’ bioavailability.
The MM120 ODT Phase III clinical development programme includes the Voyage and Panorama studies for GAD as well as the Emerge study for major depressive disorder (MDD).
In September 2023, the company completed the enrolment and dosing of 198 subjects in the Phase IIb MMED008 trial of MM-120 for GAD.