Mydecine Innovations Group announced that the U.S. Food and Drug Administration (FDA) has cleared MYCO-001 in a recent Investigational New Drug application, marking the first clearance of the Company's drug product. The Investigator Initiated trial is funded by a near $4 million grant from the National Institutes of Health. The randomized trial aims to determine if psilocybin increases smoking abstinence compared to a placebo, both paired with cognitive-behavioral therapy (CBT).

The recently cleared grant-funded trial is led by Principal Investigator (PI) Dr. Matthew Johnson, Ph.D., Professor of Psychiatry and Behavioral Sciences at Johns Hopkins University. Other PI's include Michael P. Bogenschutz, M.D., Director of the New York University (NYU) Langone Center for Psychedelic Medicine and Professor, Department of Psychiatry at NYU Grossman School of Medicine, as well as Peter Hendricks, Ph.D., professor in the Department of Health Behavior at the University of Alabama School of Public Health and a site principal investigator. The grant-funded research and Mydecine's Phase 2b study expand on previous research led by Dr. Johnson and his team.

A study conducted in 2014 assessed the efficacy of psilocybin, in combination with CBT, as a treatment for tobacco addiction. At six months, 80% of individuals were biologically proven to be smoking abstinent.