Mydecine Innovations (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared MYCO-001 in a recent Investigational New Drug (“IND”) application, marking the first clearance of the company’s drug product. According to the update, the investigator-initiated trial is funded by a near $4 million grant from the National Institutes of Health, marking the first time in 50 years the U.S. government has funded a study evaluating a psychedelic compound for therapeutic use. The purpose of the randomized trial is to determine whether psilocybin increases smoking abstinence compared to a placebo, both paired with cognitive-behavioral therapy (“CBT”). “Mydecine looks forward to supplying the placebo and our MYCO-001 drug product for this study,” said Mydecine CEO Josh Bartch. “The FDA clearance is encouraging as we prepare to submit the IND for our industry sponsored phase 2b trial using the same drug products.”
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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 to address a significant unmet need and lack of innovation in the mental health and therapeutic 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, non-psychedelic molecules with 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.
NOTE TO INVESTORS: The latest news and updates relating to MYCOF are available in the company’s newsroom at https://ibn.fm/MYCOF
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