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Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) Announces Key Meeting with UK Regulatory Agency

  • Meeting takes company a step closer to advancing its lead investigational candidate CYB003 into clinical development
  • CYB003 is designed for the treatment of two significant conditions: major depressive disorder (“MDD”) and alcohol use disorder (“AUD”)
  • CEO notes that CYB003 has the potential to achieve better patient outcomes

The coming year holds significant promise for Cybin (NEO: CYBN) (NYSE American: CYBN) for numerous reasons. The biopharmaceutical company has seen significant success in the execution of its strategic focus on progressing psychedelics to therapeutics, including its recent announcement that company representatives will hold a scientific advice meeting with the UK Medical and Healthcare Products Regulatory Agency (“MHRA”) early in 2022 (https://nnw.fm/VYu2Q). 

The meeting, which is scheduled to take place in Q1, takes the company a step closer to advancing its lead investigational candidate CYB003 into clinical development for the treatment of two significant conditions: major depressive disorder (“MDD”) and alcohol use disorder (“AUD”). CYB003 is specifically formulated to address the shortcomings of existing treatments while retaining the therapeutic benefits of oral psilocybin, the company noted. 

“We believe that CYB003 has the potential to achieve better patient outcomes, including less variability, faster onset of action, shorter duration of effect, and improved brain penetration,” said Cybin CEO Doug Drysdale. “As a society, we need to prioritize the treatment of mental health, and Cybin is committed to taking these next important steps toward progressing psychedelics to therapeutics.”

The meeting with the MHRA comes after the company announced preclinical data for CYB003 indicating that the compound demonstrated a 50% reduction in variability compared to oral psilocybin, which could mean more accurate dosing. The data also demonstrated a 50% reduction in dose compared to oral psilocybin, which potentially means that common side effects could be reduced. In addition, the data showed a 50% shorter time to onset and nearly double brain penetration, both indicators of potential benefits to developing CYB003 as an effective treatment for MDD and AUD.

“Encouraged by positive preclinical findings that demonstrated the advantages of our novel deuterated psilocybin analog over oral psilocybin for the treatment of mental health, we are moving rapidly to progress CYB003 toward clinical development,” said Drysdale. “We are looking forward to engaging with the MHRA to determine next steps for our clinical development path evaluating CYB003 for the treatment of MDD and AUD in the UK.”

In addition to its upcoming meeting with MHRA, Cybin has announced plans to file a clinical trial application with the agency in 2022.

A leading ethical biopharmaceutical company, Cybin is working with a network of world-class partners and internationally recognized scientists to create safe and effective therapeutics for patients to address a multitude of mental health issues. The company operates in the United States, the United Kingdom and Ireland. The company is focused on progressing psychedelics to therapeutics by engineering proprietary drug-discovery platforms, innovative drug-delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

For more information, visit the company’s website at www.Cybin.com.

NOTE TO INVESTORS: The latest news and updates relating to CYBN are available in the company’s newsroom at https://nnw.fm/CYBN

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