Biopharmaceutical company Cybin has selected generalised anxiety disorder (GAD), with or without major depressive disorder (MDD), as the target indication for its proprietary deuterated DMT molecule, CYB004.
Cybin is currently conducting a Phase 1 exploratory trial (CYB004-E trial) evaluating intravenous (IV) DMT to gather safety and dosing optimisation data for the future clinical development of CYB004 for the treatment of GAD.
The company has stated that, so far, the CYB004-E trial has not demonstrated any clinically significant safety or tolerability issues, and it expects to translate findings from the initial study cohorts, including dose optimisation and dosing dynamics, to support the remaining planned cohorts in the trial.
The findings are also expected to accelerate Cybin’s plans to commence dosing of CYB004 in humans.
CEO Doug Drysdale stated: “Based on preclinical data, CYB004 has shown promise in treating anxiety disorders. About half of people suffering from depression are also burdened with GAD, which makes the need for more effective treatment options for GAD even more urgent.
“Since the pandemic, the prevalence of depression and anxiety has been significantly elevated, and we are optimistic that through our current development programmes, Cybin has the potential to provide innovative therapeutics to alleviate the mental suffering that so many people experience worldwide.
“We remain focused on the opportunity that CYB004, as a new chemical entity, may be able to provide a new path toward mental healing.”
Whilst in its natural form DMT is rapidly metabolised in the body and is not orally bioavailable, Cybin has stated it believes that based on preclinical studies, CYB004 has the potential to overcome the limitations of DMT.
Data showed that CYB004 had increased oral and pulmonary bioavailability, has a faster onset with lower doses, low inter-subject variability and better dose titration for potentially fewer side effects compared with oral and IV DMT.
The company states it plans to provide an update on its CYB004 program by the end of February 2023, and also announced its plans to provide an interim readout from its Phase 1/2a trial evaluating CYB003, a deuterated psilocybin analogue, in people suffering from MDD by the end of February 2023.
CYB003 is designed to potentially address the challenges and limitations of oral psilocybin, and according to the company it has so far demonstrated less variability in plasma levels, faster onset of action, and shorter duration of effect.
