MindMed Shares Soar After FDA Approves First Commercial Clinical Trial On LSD In 40 Years

MindMed MNMD, a drug development company in the psychedelics space, announced on Tuesday that the FDA has allowed an investigational new drug application for a Phase 2b trial on a proprietary LSD analog.

Shares from the company peaked at $1.30 and closed the Tuesday trading session at $1.17, marking a 25% increase from the previous day.

The company is looking at generalized anxiety disorder as its main target indication.

The trial will focus on dose-optimization of MM-120, a “pharmacologically optimized form of LSD,” developed for generalized anxiety disorder and other brain-based disorders. 

CEO Robert Barrow said this trial represents the first commercial study of LSD in more than 40 years.

The trial plans to enroll 200 participants who will receive either a single administration of MM-120 or a placebo. The study’s primary objective is “to determine the reduction in anxiety symptoms for up to twelve weeks after a single administration of MM-120, compared across five treatment arms,” said the company in a statement, adding that the trial is expected to begin in the coming months of 2022.

“The results of this trial will guide the dose selection and development strategy for our pivotal Phase 3 clinical trials, as well as deepen our scientific understanding of the clinical effects of MM-120 and its underlying mechanisms of action,” Barrow concluded.

Image by Axel Trejo on Wikimedia Commons.