Mydecine Innovations (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced a positive meeting with the Food and Drug Administration (“FDA”) regarding the company’s Investigational New Drug (“IND”) and breakthrough therapy status applications. During the meeting, Mydecine reviewed its IND application to administer MYCO-001, in combination with therapy, to humans as part of smoking cessation treatment. Dr. Matthew Johnson of Johns Hopkins University, a leading researcher of drug and substance abuse, will serve as the lead investigator for the multisite study. “The data from John Hopkins University’s ongoing studies assessing psychedelic-assisted therapy to treat nicotine addiction is showing efficacy rates two to three times higher than the current gold standard of treatment,” said Mydecine Chief Medical Officer Dr. Rakesh Jetly. “Our team is eager to start collecting the data needed to bring an approved drug product to market that could potentially save millions of lives.”
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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.
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