Biotech company Mydecine Innovations Group (OTC:MYCOF) received FDA approval for their novel proprietary MYCO-001. This is the first clearance of the company's drug product. 

Mydecine focuses on developing first and second-generation novel therapeutics for the treatment of mental health disorders, mostly though not exclusively PTSD, depression, anxiety and addiction. The company seeks to collaborate with world authorities to responsibly fast-track the development of new medicines to provide patients with safe & effective treatment options.

The trial, conducted by Mydecine and funded by an approximate $4 million grant from the National Institutes of Health, constitutes a milestone in psychedelic studies. According to the company, this is the first time in 50 years the U.S. government has given financial aid to a study for the evaluation of a psychedelic compound for therapeutic use.

"The FDA clearance is encouraging as we prepare to submit the IND for our Industry Sponsored Phase 2b trial using the same drug products," said Mydecine CEO Josh Bartch. 

The randomized clinical study seeks to determine if psilocybin increases smoking abstinence compared to a placebo. An integration model will be used; both groups will be paired with cognitive-behavioral therapy (CBT). It is led by PI Dr. Matthew Johnson, Ph.D., Professor of Psychiatry and Behavioral Sciences at Johns Hopkins University. Johnson has more than 16 years of experience in researching and publishing on psychedelics.

The grant-funded research and Mydecine's Phase 2b study expand on a 2014 trial led by Dr. Johnson on the efficacy of psilocybin in combination with CBT as a treatment for tobacco addiction. The results: six months after the trial's start, 80% of individuals were biologically proven to be smoking abstinent.

The list of participating investigators includes Michael P. Bogenschutz, M.D., director of the NYU Langone Center for Psychedelic Medicine and professor, Department of Psychiatry at NYU Grossman School of Medicine, and Peter Hendricks, Ph.D., professor in the Department of Health Behavior at the University of Alabama School of Public Health.

Photo Courtesy of Sabine R on Unsplash.