The US food and Drugs Administration (FDA) has given approval for MYCO-001 in a recent Investigational New Drug (IND) application, which will now be used in the first US Government-funded psychedelic study in 50 years.
MYCO-001 – a synthetic psilocybin – will now be supplied for a multi-site study investigating psilocybin therapy for smoking cessation.
The randomised trial aims to determine if psilocybin increases smoking abstinence compared to a placebo, both paired with cognitive-behavioral therapy (CBT).
The trial is being carried out at Johns Hopkins University, New York University and the University of Alabama Birmingham, and will be led by Dr Matthew Johnson – a professor of psychiatry and behavioural sciences at Johns Hopkins University School of Medicine.
Johnson received an historical $4m grant from the National Institute on Drug Abuse (NIDA) to carry out the study – which was the first US Government grant in over 50 years for a study exploring the therapeutic benefits of a psychedelic compound.
Mydecine Innovations Group signed an open ended agreement with Johns Hopkins University Johns Hopkins University to study multiple molecules for multiple indications. The FDA approval for MYCO-001 for the smoking cessation study marks the first clearance of the company’s drug product.
Mydecine CEO Josh Bartch commented: “Mydecine looks forward to supplying the placebo and our MYCO-001 drug product for this study.
“The FDA clearance is encouraging as we prepare to submit the IND for our Industry Sponsored Phase 2b trial using the same drug products.”
Further Principal Investigators (PI) on the study 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 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 per cent of individuals were biologically proven to be smoking abstinent.
Mydecine senior director of clinical and regulatory affairs, Jessica Riggleman, stated: “Supportive clinical trial results have generated interest in studying psychedelic-assisted therapy across multiple indications.
“We look forward to supplying psilocybin to help advance the exploration of research in this field.”
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