Cybin Inc. (NYSE American: CYBN), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today announced positive CYB003 pre-clinical findings that demonstrate multiple advantages for its newly developed novel deuterated psilocybin analog over oral psilocybin for the treatment of mental health.
“Multiple academic studies have shown that psilocybin may have the potential to revolutionize mental healthcare, but few companies have addressed the well-known limitations and side effects of oral psilocybin. Cybin has always strived to develop safer and more effective therapies for patients, which has guided our multiple psilocybin programs: CYB001, CYB002, and CYB003,”Doug Drysdale, Cybin’s Chief Executive Officer.
Academic research performed at New York University and John Hopkins University has indicated oral psilocybin to be efficacious in the treatment of mental health disorders, especially MDD, but with significant limitations, specifically: slow onset of action, extended duration of effect, and a variability in response among patients. The Company’s CYB001 and CYB002 programs studied proprietary formulations, while the Company’s CYB003 program explored proprietary analogs with the goal to retain the benefits and address the challenges. Today the Company is pleased to announce that its proprietary molecular advancements offer positive benefits and address the challenges and limitations of oral psilocybin.
In multi-species pre-clinical studies, the Company’s deuterated psilocybin analog from its CYB003 program demonstrates:
- 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 deuterated psilocybin analog in CYB003 has the potential to reduce time and resource burden on patients, providers and payers, and possibly improving scalability and accessibility from the following conclusions:
- faster onset of action equates to less down time in the clinic before effects begin;
- half the duration of effect translates to shorter clinic days or more patients per day;
- more predictable dose effects create a safer and more effective patient response;
- lowered peripheral exposure diminishes the risk of nausea; and
- better brain penetration suggests lower overall dose needed to achieve clinical efficacy.
“While we are all encouraged by the benefits of psilocybin, we need to transparently and openly discuss its limitations if we are to translate psychedelics to therapeutics for patients in need. The majority of current clinical studies are based on psilocybin. We have taken the necessary steps to potentially unlock the powerful benefits of psychedelics and engineer a superior molecule as demonstrated by the data. We are on a mission to make ethical, safe scientific progress to advance the care and treatment of mental health patients. Our goal has always been to be a leader in creating the best therapy for patients, today we move one step closer,” said Doug Drysdale, Cybin’s Chief Executive Officer.
The presentation showcasing the Company’s data will be made available on the Cybin website within 24 hours.
As a reminder, the Company welcomes all media and analysts that are attending the Wonderland Conference in Miami to physically join its presentation today at 8:30am EDT.
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 USA, UK 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.