Cybin Inc. is exploring the possibility that its psilocybin analogue CYB003 could be a potential treatment for major depressive disorder (MDD).
In vivo preclinical studies have shown that CYB003 was well-tolerated following several doses in multiple species.
The company has stated that the results support the advancement toward an investigational new drug filing with the US Food and Drug Administration for a Phase 1/2a first-in-human clinical trial in patients with MDD.
Chief medical officer of Cybin, Dr Amir Inamdar, commented: “We are excited to complete this integral step toward moving CYB003 into the clinic – an impressive journey that took less than 18 months since discovery of the CYB003 molecule.
“Based on its attractive preclinical profile and the ability to translate these results in patients, we believe that CYB003 has the potential to be a novel and effective treatment for the many people suffering from MDD.”
“The completion of these in vivo preclinical studies for CYB003 represents a significant milestone toward advancing this program into first-in-human clinical development and brings us one step closer to progressing CYB003 as a best-in-class treatment candidate for mental illness and addiction,” added Doug Drysdale, CEO of Cybin.
“We plan to focus the Phase 1/2a trial in the United States. We believe this will allow us to escalate the study through early-stage clinical development and into a potential broader Phase 2b trial, while concurrently collecting a large amount of data to support late-stage studies.”
The preclinical results demonstrated that the analogue has a well-tolerated profile; a similar in vitro and in vivo pharmacology profile when compared to psilocin; a 50 per cent reduction in variability compared to classic psilocybin: a 50 per cent dose reduction compared to classic psilocybin; and a 50 per cent shorter time to onset when compared to classic psilocybin.
Cybin has stated it also has nearly double the brain penetration when compared to classic psilocybin, indicating the potential for a less variable treatment response. Cybin is now planning to submit an IND to the FDA in the second quarter of 2022 and to initiate the Phase 1/2a clinical trial in mid-2022.
[activecampaign form=52]
