Shares of Mind Medicine (NASDAQ:MNMD) surged around 16% premarket on Thursday after the U.S. Food and Drug Administration (FDA) granted breakthrough designation to its MM120 (lysergide d-tartrate) program for the treatment of generalized anxiety disorder.
In a Phase 2b study, a single oral administration of MM120 100 µg met its key secondary endpoint and maintained a clinically and statistically significant reductions on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at 12 weeks with a 65% clinical response rate and 48% clinical remission rate.
The company previously announced clinically meaningful, and statistically significant improvements on the HAM-A scale compared to placebo at Week 4, which was the trial’s primary endpoint.
MindMed (MNMD) 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.
The company plans to hold an End-of-Phase 2 meeting with the U.S. drug regulator in the first half of 2024 and initiate its Phase 3 clinical program in the second half of 2024.