Mydecine Receives Conditional IRB Approval for Phase 2b Smoking Cessation Study
Mydecine Innovations Group has received conditional approval from the Institutional Review Board (IRB) for its Phase 2b smoking cessation trial, with Johns Hopkins University as the lead site. The trial aims to evaluate MYCO-001 with hopes of submitting an Investigational New Drug (IND) application to the FDA in Q2 2022. Mydecine aims to be the first commercial IND approved for psilocybin in this indication. The total cost of smoking in the U.S. is over $300 billion annually. The trial’s primary endpoint is six months, with data expected by Q4 2023.
- Conditional IRB approval for Phase 2b trial of MYCO-001 received.
- Aiming to submit an IND application in Q2 2022, potentially leading to FDA approval.
- First commercial IND for psilocybin aimed at smoking cessation, indicating a strong market position.
- Potential positive impact on mental health treatment for millions, addressing significant economic costs.
- Approval contingent on FDA clearance of IND application, creating potential delays.
- The long timeline for results, with data not expected until Q4 2023.
Clinical trial programs advance to further assess psychedelic-assisted psychotherapy utilizing lead drug candidate MYCO-001
DENVER, March 24, 2022 (GLOBE NEWSWIRE) -- Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced it has received conditional approval from the Institutional Review Board (IRB) for its multi-site Phase 2b smoking cessation trial. Johns Hopkins University will serve as the lead investigational site.
The Company reported the IRB has approved its Phase 2b smoking cessation study pending FDA approval of its Investigational New Drug (IND) application. Mydecine plans to submit the IND application in Q2 2022 and is hopeful it will go into effect 30 days after submission.
“We are beyond excited to share the news of our conditional IRB approval for our Phase 2b clinical trial. 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,” said CEO Josh Bartch.
“This conditional approval marks a significant milestone not only for Mydecine but for people around the globe. The total economic cost of smoking has been estimated to be more than
"Today's accomplishment speaks to the perseverance and dedication of our team as we continue to build on our clinical and commercial potential,” added Mydecine’s Senior Director of Clinical and Regulatory Affairs Jessica Riggleman. “Our success is built upon a strategic collaboration between our contract research organization, manufacturer, investigators, advisors and regulatory consultants. We are diligently working together to submit our Investigational New Drug Application to the FDA for our multi-regional Phase 2b clinical trial.”
The Company will move rapidly into the patient recruitment phase upon FDA clearance. Mydecine’s Phase 2b study is investigating a primary endpoint of six months, indicating it could publish data as early as Q4 2023.
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About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) 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. Our 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, 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.
Learn more at: https://www.mydecine.com and follow us on Twitter, LinkedIn, YouTube and Instagram.
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Joshua Bartch, Chief Executive Officer
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For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.
This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company's ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company's products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.
FAQ
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