MindMed Nears Milestones in LSD-Based Treatment Trials

MindMed’s MM-120 is in the Phase 2b stage under FDA evaluation.

Mind Medicine Inc. expects to receive initial results for its LSD dose-optimization trial targeting generalized anxiety disorders by year-end, according to the company’s third-quarter earnings update.

The trial, involving MindMed’s MM-120, is in the Phase 2b stage under FDA evaluation. Despite reporting a net loss of $17.9 million for the quarter ending Sept. 30, the New York-based company allocated $13.2 million for research and development, marking a substantial increase from the previous year.

MM-120, an optimized form of LSD developed for anxiety disorders and other brain-related conditions, enrolled 198 participants who received single oral doses of MM-120 (ranging from 25 µg to 200 µg) or a placebo. The results will shape dosage decisions and strategy for MindMed’s pivotal Phase 3 clinical trials, said Robert Barrow, CEO and director of MindMed, when announcing the beginning of the Phase 2b trial in January 2022.

The company expects to release 12-week safety and efficacy outcomes by Q1 2024.

MindMed also is making progress on a proof-of-concept study assessing the repeated low-dose use of MM-120 for adult attention-deficit/hyperactivity disorder, with expected top-line results in early 2024.

Additionally, the company plans to initiate its first clinical trial for MM-402, an MDMA formulation, by year-end. The trial aims to explore MM-402’s potential in treating autism spectrum disorder, with the University Hospital Basel in Switzerland actively enrolling participants for the Phase 1 investigator-initiated trial.