MindMed (NASDAQ:MNMD; NEO:MMED) announced first patient dosing in its Phase 2b dose-optimization trial of MM-120, a pharmaceutically optimized form of lysergic acid diethylamide (LSD), for the treatment of generalized anxiety disorder (GAD).
“This exciting next step in the advancement of LSD builds on the positive topline data presented by our partners at University Hospital Basel in May 2022, which demonstrated the rapid, durable, and statistically significant effects of LSD and its potential to safely mitigate symptoms of anxiety and depression,” Robert Barrow, CEO of MindMed, said in a statement.
He said the results of the Phase 2b trial will guide dose selection and development strategy for pivotal Phase 3 clinical trials, as “we continue our efforts to bring a new potential treatment to the millions of people living with GAD.”
The Phase 2b trial in patients diagnosed with GAD is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial plans to enroll 200 participants who will receive a single administration of up to 200 microg of MM-120 or placebo.
The primary objective is to determine the reduction in anxiety symptoms four weeks after a single administration of MM-120, compared across the five treatment arms. Key secondary objectives, measured up to 12 weeks after the single administration, include assessments of safety and tolerability as well as quality of life.