NetworkNewsBreaks – Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) Announces IRB Approval for Planned Smoking Cessation Study
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.”
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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.”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
