Cybin Inc. (NYSE: CYBN), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™” is pleased to announce that it has confirmed a scientific advice meeting with the UK Medical and Healthcare Products Regulatory Agency for the first quarter of calendar year 2022. This program milestone brings the Company closer toward advancing its lead investigational candidate CYB003 into clinical development for the treatment of major depressive disorder and alcohol use disorder.

“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. 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,”

Doug Drysdale, Chief Executive Officer of Cybin

“CYB003 was designed to address the shortcomings of existing treatments, while retaining the therapeutic benefits of oral psilocybin. 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. 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,” concluded Drysdale.

On November 8, 2021, the Company reported preclinical data for CYB003 demonstrating:

  • a 50% reduction in variability compared to oral psilocybin; indicates potential for more accurate dosing in patients with MDD and AUD;
  • a 50% reduction in dose compared to oral psilocybin; indicates potential to maintain equivalent efficacy while reducing side effects, such as nausea, in patients with MDD and AUD;
  • a 50% shorter time to onset when compared to oral psilocybin; indicates potential for shorter duration of treatment, lower inter-subject variability, better therapeutic control and safety, leading to a better patient experience, with lower cost and scalability; and
  • nearly double brain penetration when compared to oral psilocybin; indicates potential for a less variable treatment response, a lower dose therapeutic effect, and reduced patient side effects.

The Company plans to file a clinical trial application with the MHRA in the second quarter of calendar year 2022.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in the United States, 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.