Mydecine Innovations (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) is a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders. Mydecine has announced that, in preparation for its FDA pre-Investigational New Drug (“IND”) meeting on Feb. 28, the company has submitted a pre-IND briefing package to the U.S. Food and Drug Administration (“FDA”) for a clinical study evaluating MYCO-001 in a structured smoking cessation treatment program. Principal Investigator Dr. Matthew Johnson, Ph.D., professor of psychiatry and behavioral sciences at Johns Hopkins University, will lead the study that will assess the safety and efficacy of psilocybin-assisted psychotherapy utilizing MYCO-001 to treat tobacco addiction. “We are excited to move forward on this important study, and our team has been working diligently to ensure that our pre-IND package is complete,” said Mydecine CEO Josh Bartch. “Tobacco use is the greatest single, preventable cause of death in the world, yet there are few safe and effective treatments for nicotine addiction. As the only company currently investigating a psilocybin compound for smoking cessation, Mydecine is proud to be at the forefront of this research.”
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About Mydecine Innovations Group
Mydecine is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and treatment environments. The company’s global team is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. Mydecine’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise, with a focus on psychedelic therapy as well as other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands. For more information about the company, please visit www.Mydecine.com.
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