Development Pipeline
Development Pipeline
Leading the Industry in Developing Proprietary Psychedelic-Based Therapeutics
Research and Development Progress
PROGRAM(1) (2)
- DISCOVERY
- PRECLINICAL
- PHASE 1
- PHASE 2
- PHASE 3
- REGISTRATION
CYB003-Deuterated Psilocybin Analog
Major Depressive Disorder
Phase 1/2a trial underway
CYB004-Deuterated Dimethyltryptamine (DMT)
Generalized Anxiety Disorder
CYB004-E Phase 1 trial underway
CYB003-Deuterated Psilocybin Analog
Alcohol Use Disorder
PHASE 1
CYB005-Phenethylamine Derivative
Neuroinflammation
PRECLINICAL
CYB002 – Amorphous Psilocybin ODT
Undisclosed
PRECLINICAL
Other
Undisclosed
PRECLINICAL
Mental Distress in Healthcare Workers 3
EMBARK – Psilocybin for mental distress in frontline healthcare workers
Phase 2 IIT study underway
Psychedelic Effects On Brain4
Kernel Flow - Neuroimaging Technology
Feasibility study completed
Q3 2022
CYB003 Phase 1/2a MDD patient study
Initiated CYB003 Phase 1/2a MDD patient study
.
Q4 2022
Preclinical data expected for CYB005
Potential CYB003 interim safety and PK data readout
Expect data from Phase 1 Kernel Flow® feasibility study
Plan to nominate CYB005 partnering candidate
NOTES:
- Forward-looking statements are subject to risks and assumptions. Subject to receipt of all necessary regulatory approvals from all applicable governmental authorities, including, as applicable, the academic and scientific organizations with which Cybin is working.
- Subject to receipt of all necessary regulatory approvals from all applicable governmental authorities, including, as applicable, the academic and scientific organizations with which Cybin is working. There are multiple risk factors regarding the ability to successfully commercially scale a chemically synthesized process to obtain psilocybin and other analogues.
- Phase 2 investigator-initiated study being conducted by Dr. Anthony Back, professor of medicine (oncology) at the UW School of Medicine and co-funded by Cybin.
Cybin-sponsored Phase 1 feasibility study conducted by Kernel evaluating Kernel’s Flow Technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics.
Q3 2022
Initiate CYB003 Phase 1/2a MDD patient study
Continue to progress CYB004-E Phase 1 clinical trial
.
Q4 2022
Preclinical data expected for CYB005
Potential CYB003 interim safety and PK data readout
Expect data from Phase 1 Kernel Flow® feasibility study
Plan to nominate CYB005 partnering candidate
Upcoming Value-Driving Milestones
Q1 2023
Complete CYB003 Phase 1 to assess safety, PK and psychedelic effects
Initiate CYB003 dosing in MDD cohorts
Approval for first-in-human dosing of CYB004
Initiate DMT (Part B) dosing in CYB004-E study
Q2 2023
Complete GMP manufacturing for CYB004
Initiate CYB004 first-in-human dosing (early Q2)
Initiate bioequivalence cohort for CYB003 for capsules
Q3 2023
Complete CYB003 dosing in MDD cohorts
Topline data readout from CYB004-E trial, including DMT and CYB004 cohorts
Topline data readout from CYB003 Phase 1/2a clinical trial (late Q3)
.
Q4 2023
FDA submission of CYB003 Phase 1/2a for pivotal studies
2022 HIGHLIGHTS
ANTICIPATED MILESTONES(1)
Initiated Phase 1/2a first-in-human clinical trial evaluating CYB003 for treatment of MDD
Interim safety & PK readout expected in early CY2023
Accelerated development of CYB004 through acquisition of Phase 1 clinical trial evaluating IV DMT
Update expected in early CY2023
Supported investigator-initiated Phase 2 study evaluating EMBARK psychedelic facilitator training program in combination with psilocybin to treat frontline healthcare workers
Expand EMBARK training to support psychedelic-based therapies
Initiated co-sponsored feasibility study evaluating Kernel Flow quantitative neuroimaging technology to measure psychedelic effects on brain
Data expected first quarter CY2023 to inform next steps
2022 HIGHLIGHTS
ANTICIPATED MILESTONES(1)
Initiated Phase 1/2a first-in-human clinical trial evaluating CYB003 for treatment of MDD
Interim safety & PK readout expected in early CY2023
Accelerated development of CYB004 through acquisition of Phase 1 clinical trial evaluating IV DMT
Update expected in early CY2023
Supported investigator-initiated Phase 2 study evaluating EMBARK psychedelic facilitator training program in combination with psilocybin to treat frontline healthcare workers
Expand EMBARK training to support psychedelic-based therapies
Initiated co-sponsored feasibility study evaluating Kernel Flow quantitative neuroimaging technology to measure psychedelic effects on brain
Data expected first quarter CY2023 to inform next steps
Lead Clinical Development Programs
CYB003: Deuterated Psilocybin Analog
CYB003 is a proprietary molecule derived from psilocybin, which is part of a family of molecules called indolamines that includes more common neurotransmitters like serotonin. Psilocybin is dephosphorylated to form its metabolite, psilocin, which can cross the blood-brain-barrier. Given its structural similarity to serotonin, psilocybin can easily activate the serotonin 5-HT2A receptor. CYB003 is a deuterated psilocybin analog being developed to achieve low variability in plasma levels, and fast onset and short duration of effect, at low doses to potentially provide a safer and more effective outcome for patients and providers.
CYB003 is being evaluated as a potential treatment for Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD) and is the first ever deuterated psilocybin analog to enter clinical development.
Current Status: Positive interim data for Phase 1/2a trial released; Topline efficacy data expected in Q4 2023
CYB004: Deuterated N,N Dimethyltryptamine (dDMT)
CYB004 is a deuterated dimethyltryptamine (dDMT), which 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. Based on 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 has a longer duration of effect compared to DMT, indicating the potential to extend the therapeutic window and provide better dose optimization. By maximizing CYB004 as a deuterated molecule and improving upon the bioavailability of DMT, CYB004 has the potential to offer less invasive and more convenient dosing methods.
CYB004 is being evaluated as a potential treatment for anxiety disorders, specifically Generalized Anxiety Disorder. CYB004 is secured by a U.S. composition of matter patent with protection through 2041. The patent covers a range of deuteration forms of DMT and protects CYB004 as a putative new chemical entity.
Current status: Phase 1 CYB004-E clinical trial underway evaluating IV DMT and CYB004 in health volunteers; Topline data expected in Q3 2023
CYB004: Deuterated Dimethyltryptamine (DMT)
CYB004 is a deuterated dimethyltryptamine (DMT), which 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, unstable and not orally bioavailable. Based on preclinical studies, deuterated DMT has the potential to overcome these limitations and provide increased oral and pulmonary bioavailability, faster onset with lower doses, less 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 Generalized Anxiety Disorder with or without major depressive disorder.
Current status: Conducting Phase 1 in-human study evaluating 50 healthy volunteers
CYB004: Deuterated N,N Dimethyltryptamine (dDMT)
CYB004 is a deuterated dimethyltryptamine (dDMT), which 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. Based on 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 has a longer duration of effect compared to DMT, indicating the potential to extend the therapeutic window and provide better dose optimization. By maximizing CYB004 as a deuterated molecule and improving upon the bioavailability of DMT, CYB004 has the potential to offer less invasive and more convenient dosing methods.
CYB004 is being evaluated as a potential treatment for anxiety disorders, specifically Generalized Anxiety Disorder. CYB004 is secured by a U.S. composition of matter patent with protection through 2041. The patent covers a range of deuteration forms of DMT and protects CYB004 as a putative new chemical entity.
Current status: Phase 1 CYB004-E clinical trial underway evaluating IV DMT and CYB004 in health volunteers; Topline data expected in Q3 2023
Our Work
Patents
Cybin has multiple patent filings covering a wide range of novel psychedelic compounds from different classes, including targeted structural modifications to improve the drug pharmacokinetic characteristics and safety profiles without altering their receptor binding.
These novel drug delivery platform claims are expected to enable administration of the psychedelic drugs with faster onset of action, higher bioavailability by way of bypassing the liver metabolism, and expected to offer more control for better patient experience and optimized therapeutic outcomes.
Cybin was granted a patent by the USPTO for CYB004, its proprietary deuterated DMT molecule, in February 2022. The allowed claims include a range of deuterated forms of DMT and 5-MeO-DMT, and protects CYB004 drug substance as a putative new chemical entity.
Our 3 Pillar Strategy
Novel Drug Discovery Platform
API Modification
Develop new API’s via selective modifications of tryptamine and phenethylamine-based scaffolds specifically to alter their pharmacokinetics without modifying their therapeutic potential.
Modifications involve replacing selective hydrogens with deuterium atoms.
Optimizing unique physicochemical attributes e.g. salts, crystal forms, co-crystals, etc.
Proprietary Drug Delivery Systems
Research and Development
Efficient delivery system that attempts to bypass the liver metabolism with a direct path to the brain providing a faster onset of action.
Modified-release formulations with the potential to reduce side effects and to control exposure.
Dose control through proprietary device platform.
Delivery systems may be applied to many psychedelic compounds.
Innovative Treatment Regimen
Science Meets Technology
Software-based platform to gather clinical research data from psychedelic treatment.
EMBARK six domain best-practices psychotherapy program designed to provide consistent therapist training and consistent psychotherapy delivery in clinical trials.
Advancing Mental Healthcare Through Evidence Based Therapeutics
CYB001
PHASE IIA & PHASE IIB CLINICAL TRIAL
SUBLINGUAL PSILOCYBIN IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER (MDD)
PHASE IIA
Randomized Parallel Group Open Label BE Study
PSILOCYBIN (PY)
PHASE IIB
Randomized Double Blind Placebo Controlled Safety & Efficacy Study
MDD patients with moderate depression (MADRS score 18-34)
Primary efficacy in 30 days
Patients will be followed for 4 months for safety and efficacy
Duration: approx 12 months
Clinical trial will adhere to ICH and GCP guidelines, with the aim to utilize clinical data in jurisdictions such as USA, Canada and Europe.