Mydecine Innovations (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, has received conditional approval from the Institutional Review Board (“IRB”) for its planned multisite phase 2b smoking cessation trial. According to the announcement, Johns Hopkins University will serve as the lead investigational site for the study. The company anticipates submitting its IND application in the second quarter, with hopes that the study will begin shortly thereafter. Calling the approval a “significant milestone,” the company noted that its mission is to provide safer, more effective solutions to address nicotine dependence and other harmful addictions and this approval is one step closer to achieving that goal. “We are beyond excited to share the news of our conditional IRB approval for our Phase 2b clinical trial,” said Mydecine Innovations CEO Josh Bartch in the press release. “Upon the near-term clearance of our IND application, which is wholly owned by Mydecine, we will be the first commercial IND approved utilizing psilocybin for the indication of smoking cessation, and one of a small number of organizations with a commercial FDA IND approval, alongside COMPASS Pathways, MindMed and Usona, for a Phase 2 or later stage study assessing a psychedelic compound for any indication. We have a strong patent and regulatory strategy to support this initiative as well as further subsequent approvals.”
To view the full press release, visit https://ibn.fm/a3Ry7
About Mydecine Innovations Group
Mydecine Innovations is a biotechnology company developing innovative first- and second-generation novel therapeutics for the treatment of mental health and addiction using 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 new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy as well as other novel, nonpsychedelic 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, 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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