Cybin is to meet with the UK’s Medical and Healthcare Products Regulatory Agency (MHRA) to discuss its lead psychedelic candidate CYB003 as a treatment for Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD).
Biopharmaceutical company Cybin Inc. will be attending a scientific advice meeting with the MHRA to discuss the use of its lead psychedelic candidate – CYB003- an analogue of psilocybin. The meeting will take place in the first quarter of 2022.
Cybin has stated the development brings the company closer toward advancing CYB003 into clinical development for the treatment of the conditions.
Cybin CEO, Doug Drysdale, commented: “Encouraged by positive preclinical findings that demonstrated the advantages of our novel deuterated psilocybin analogue 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.
“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 prioritise the treatment of mental health, and Cybin is committed to taking these next important steps toward progressing psychedelics to therapeutics.”
Preclinical data on CYB003 has demonstrated that it has a 50 per cent reduction in variability compared to oral psilocybin, indicating the potential for more accurate dosing in patients with MDD and AUD; and a 50 per cent reduction in dose compared to oral psilocybin which suggests its use could maintain equivalent efficacy while reducing side effects.
The data also demonstrated the analogue has a 50 per cent shorter time to onset when compared to oral psilocybin. This data indicates the analogue has the potential for shorter duration of treatment, as well as lower inter-subject variability, better therapeutic control and safety and lower cost and scalability.
Additionally, Cybin states it has 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.
Cybin plans to file a clinical trial application with the MHRA in the second quarter of calendar year 2022.
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