Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) has now made some considerable progress on its mission to treat Generalized Anxiety Disorder (GAD).
On Thursday, the New York-based biopharmaceutical company happily announced that it had administered the first dose of MM-120 in its new Phase 2b trial.
MM-120 is a pharmaceutically altered form of LSD developed by the organization.
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MindMed is a company headquartered within the World Trade Center in New York City. The organization is currently focused on developing a series of innovative psychedelic drug candidates for the treatment of mental health conditions, including its optimized LSD compound.
The new Phase 2b clinical trial will be enrolling approximately 200 participants ages 18-75 who suffer from GAD and will wholly commence on August 27. It will be a “multi-centre, parallel, randomized, double-blind, dose-optimization study” with a primary objective of determining the rate of reduction in anxiety symptoms four weeks after subjects receive a single dose of MM-120.
There will be five treatment arms beginning with a placebo followed by the administration of 25 micrograms of the compound. Doses will then be gradually increased for the remaining three arms in the trial. Participants will be receiving up to 200 micrograms of the LSD derivative or placebo just once, and key secondary objectives will include evaluations of safety and tolerability along with changes in overall quality of life that will be assessed 12 weeks after the trial has concluded.
MindMed says that approximately 6 per cent of adults in the U.S. will suffer from GAD during their lifetime.
“The initiation of our Phase 2b clinical trial, the largest well-controlled clinical trial of LSD ever conducted, represents a major milestone for MindMed and for the many patients suffering from GAD,” said Robert Barrow, CEO and Director of MindMed.
“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,” added Barrow.
“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 GAD.”