MindMed announces initial patient dosing in phase 2b trial of LSD-based anxiety treatment

A biopharmaceutical company has announced the first patient dosing in its phase 2b dose-optimization trial of MM-120, a form of lysergic acid diethylamide utilized for the treatment of generalized anxiety disorder.

According to a release issued by Mind Medicine Inc., this step in the advancement of LSD for therapeutic purposes builds on positive topline data presented in May by clinicians at University Hospital Basel in Switzerland, which demonstrated the rapid, durable and statistically significant effects of LSD and its potential to safely mitigate symptoms of anxiety and depression.

“The initiation of our phase 2b clinical trial represents a major milestone for MindMed and for the many patients suffering from [generalized anxiety disorder],” Robert Barrow, CEO and director of MindMed, said in the release. “The results of our phase 2b trial will guide the dose selection and development strategy for our pivotal phase 3 clinical trials, as we continue our efforts to bring a new potential treatment to the millions of people living with [generalized anxiety disorder]."

The current clinical trial including patients diagnosed with generalized anxiety disorder (GAD) is a multicenter, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial is expected to enroll 200 participants who will receive a single dose of up to 200 µg of MM-120 or placebo.

The primary objective of the study is to determine the reduction in anxiety symptoms 4 weeks after a single administration of MM-120, compared across the five treatment arms. Key secondary objectives, measured up to 12 weeks after initial dosage, include assessments of safety and tolerability as well as quality of life, the company stated in the release.