CYB004

CYB004
Deuterated Dimethyltryptamine (dDMT)

Cybin is developing CYB004 for the treatment of Anxiety Disorders, specifically Generalized Anxiety Disorder (GAD). CYB004, a deuterated dimethyltryptamine (dDMT), has been shown to exert its psychedelic effects by activating the 5-HT2A receptor.

In its regular form, DMT is an unstable molecule rapidly metabolized in the body, which significantly reduces its bioavailability. CYB004 has the potential to overcome the limitations of DMT. 

Cybin has been granted a composition of matter 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.

CYB004 Demonstrates Positive Preclinical Results

In preclinical studies, CYB004 has demonstrated an improved bioavailability and pharmacokinetic profile in comparison to DMT when administered via intravenous and inhaled routes. These studies also demonstrated that IV CYB004 had a longer duration of effect compared to DMT indicating the potential to extend the therapeutic window and provide better dose optimization.

Improved Bioavailability = potential for lower dosing and reduced side effects
Modified Duration = improved therapeutic window
Deuteration = potential for less invasive dosing methods for patients

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Developing CYB004 as a Potentially More Viable Treatment Option for Anxiety Disorders

Cybin is currently conducting one of the largest Phase 1 DMT clinical trials to date.  This 3-part Phase 1 trial is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of escalating doses of DMT and CYB004 in healthy volunteers. 

CYB004E Study Design Overview

Part A:
DMT SAD 

Part A: DMT (Single Ascending Dose)

Acquired study in smokers

Single Ascending Dose

90-minute infusion

4 cohorts completed

Part B:
DMT

Part B: DMT (Bolus + Infusion)

Amendments to protocol:

Non-smokers only

Change to bolus + infusion

Shorter infusion duration

Flexible dose exploration

Dosing completed

Part C:
CYB004 (dDMT) FIH

Part C: CYB004 (FIH)

Amendments to protocol:

Inclusion of CYB004 FIH

Bolus + infusion

Shorter infusion duration

Flexible dose exploration

Initiated CYB004 dosing

Data from Part A of the Phase 1 trial suggest DMT was well-tolerated within
evaluated dose range, with dose-related increases in both exposure and PD/behavioral effects

Data from Parts B and C will be used to build a robust PK/PD model to support dose optimization for future clinical studies

Scientific Rationale

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

As a deuterated molecule, CYB004 improves upon the bioavailability of DMT that may offer less invasive and more convenient dosing methods

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