Kicking off the Microdose Wonderland conference in Miami, Cybin Inc announced it will be moving its psilocybin analogue – CYB003 – into clinical trials.
Cybin, which operates across Canada, the USA, the UK and Ireland, says the company will be to conducting the clinical trials in the UK and USA.
In a bid to develop a compound that is more suited to clinical treatment, the company has developed the analogue of psilocybin for Alcohol Use Disorder, which it says has a faster onset of action, shorter duration of action and reduces side effects such as nausea.
“We are harnessing already known attributes of classical psychedelics, like psilocybin, and we are engineering them into commercially viable therapeutics that are accessible to all those that need them,” said Cybin CEO Doug Drysdale. “In just the past 12 months, we have completed 74, preclinical studies across our programmes and established 50 professional partnerships with world-class scientists and advisors and clinical research organisations.
“I think we are all excited about the academic studies that have shown efficacy with psilocybin, but it does have significant limitations, and Cybin is a biopharmaceutical company,” said Drysdale. “Our goal is to transform these molecules into useful practical therapeutics through regulatory pathways.
“These data and molecular possibilities may have wide reaching implications for the treatment of mental health. And all of us here are aware of the enormous unmet need in this space.
Sharing data on the analogue, Cybin’s chief research and development officer, Dr Michael Palfreyman, said: “The oral psilocybin analogue has been designed to have less variability in plasma levels, to have a faster onset of action, to have a shorter duration of action, and to have better brain penetration, which is of course where it works.
“We have done many different studies in multiple a number of different animal species in the preclinical studies, with models for psychedelic action, studying pharmacokinetic profiling, and then following the safety regulations that FDA requires for advancing a programme towards eventual clinical use. And we have done all of this to predict an efficacious and effective and safe human dose.”
Chief operating officer, Aaron Bartlone, commented: “We will be filing an IND with the US FDA and clinical trial applications with the Medicines and Healthcare Regulatory Agency in the UK (MHRA).
“In quarter two and we will then progress upon regulatory approval or early phase studies in major depressive and alcohol use disorder. Leveraging again our proprietary embarked psychotherapy programme, subsequently then executing those trials in the US and UK. We have capabilities to progress this molecule rapidly.”
