Mind Medicine (MindMed) Inc. announced that FDA has granted breakthrough designation to its MM120 (lysergide d-tartrate) program for the treatment of generalized anxiety disorder (GAD). The Company also announced that its Phase 2b study of MM120 in GAD met its key secondary endpoint, and 12-week topline data demonstrated clinically and statistically significant durability of activity observed through Week 12. MindMed previously announced rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4, which was the trial?s primary endpoint.

MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention. MM120 100 µg ? the dose with optimal clinical activity observed in the trial ?

demonstrated a 7.7-point improvement over placebo at Week 12 (-21.9 MM120 vs. -14.2 placebo; p<0.003 Cohen?s d=0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to Week 12. Clinical Global Impressions - Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg dose group, representing a two-category shift from ?markedly ill?

to ?borderline ill? at Week 12 (p<0.004). This clinical activity was rapid, observed as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between Weeks 4 and 12.

Based on the significant unmet medical need in the treatment of GAD ? especially in patients who do not respond to or tolerate currently available medications ? along with the initial clinical data from Phase 2b and other research conducted by MindMed, the U.S. Food & Drug Administration (FDA) has designated MM120 for GAD as a breakthrough therapy.

The Company plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and initiate a Phase 3 clinical program in the second half of 2024. In the Phase 2b study, known as MMED008, MM120 was generally well-tolerated with most adverse events rated as mild to moderate, transient and occurring on dosing day, and being consistent with expected acute effects of the study drug. The most common adverse events (at least 10% incidence in the high dose groups) on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis and hyperhidrosis.

Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of study-related psychotherapy for the duration of their participation in the study. The primary data analyses from MMED008 have been accepted for presentation at the American Psychiatric Association?s annual meeting, which will be held in New York on May 4-8, 2024. The study is also being submitted for publication in a leading medical journal.