Deuterated Dimethyltryptamine (DMT)
Cybin is developing CYB004 for the treatment of anxiety disorders. CYB004, a deuterated dimethyltryptamine (DMT), has been shown to exert its psychedelic effects by activating the 5-HT2A receptor.
In its natural form, DMT is rapidly metabolized in the body and is not orally bioavailable. Preclinical studies have demonstrated that CYB004 has the potential to overcome these issues and provide increased oral and pulmonary bioavailability, faster onset with lower doses, low inter-patient variability, and better dose titration for fewer side effects and longer acting desensitization of the serotonergic receptors.
CYB004 has the potential to effectively treat anxiety disorders, including Generalized Anxiety Disorder GAD and Social Anxiety Disorder SAD.
CYB004 Demonstrates Positive Preclinical Results
Preclinical studies have shown that inhaled CYB004 demonstrated significant advantages over both IV DMT and inhaled DMT, including longer duration of action and improved bioavailability. The study also demonstrated that inhaled CYB004 showed a similar onset of effect and dose profile to IV DMT.
Cybin believes these data may support the potential for inhalation as a viable and well-controlled delivery system of therapeutic psychedelics allowing treatment to be more patient-friendly.
CYB004 Demonstrates Promising Preclinical Results
Approximately 2000% improved bioavailability compared with orally administered DMT, which is known to have limited to no oral bioavailability
Approximately 41% improved bioavailability compared with inhaled DMT
Approximately 300% longer duration of effect when compared to IV DMT, indicating potential to extend therapeutic window
Developing CYB004 as a Potentially More
Viable Treatment Option for Anxiety Disorders
Approximately 2000% improved bioavailability compared with orally administered DMT, which is known to
have limited to no oral bioavailability
Approximately 41% improved
bioavailability compared with
Approximately 300% longer
duration of effect when compared
with IV DMT, indicating potential to
extend therapeutic window
Rapid onset of effect and similar low variability equivalent to IV DMT
Improved Bioavailability = potential for lower dosing and reduced side effects
Modified Duration = improved therapeutic window (IV DMT at ~6-10 minutes v. CYB004 at ~30 minutes)
Inhalation Delivery = less invasive option for patients than IV
Note: Expectations for the potential benefits of CYB004 are based on preclinical data.
DMT has agonistic actions on a range of 5-HT receptors
Efficacy demonstrated in a range of observational and
real-world studies in depression, anxiety and substance use disorders
Inhalation provides a similar dose profile as IV DMT and is easier to administer
Cybin is currently conducting the largest Phase 1 DMT clinical study to date. This adaptive, randomized, double-blind, placebo-controlled, single ascending dose study is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of a target-controlled intravenous infusion of DMT in 50 healthy volunteers who smoke tobacco. The Phase 1 study is being conducted in the Netherlands at the Centre for Human Drug Research (CHDR) and is expected to potentially yield essential safety and dosing data and provide the foundation for additional research on the therapeutic potential of DMT.
The primary objectives of the study are to: Evaluate the safety of increasing doses of a single dose continuous DMT infusion over 90 minutes; Characterize the PK of a single dose DMT administered continuously over 90 minutes; Characterize the PD of a single dose DMT administered continuously over 90 minutes; and Establish the minimum DMT dose required to produce a psychedelic effect.
Cybin has been granted a patent from the USPTO that covers new chemical entity claims for CYB004 until 2041.
The World Intellectual Property Organization WIPO has published an international patent application for Cybin covering inhalation delivery methods for multiple psychedelic molecules that are currently being researched and developed by the company as well as other psychedelic molecules that may be developed in the future.