Leading the Industry in Developing Proprietary Psychedelic-Based Therapeutics

Our pipeline is derived from our novel drug discovery platform

PROGRAM1
Mental Distress in Healthcare Workers2

EMBARK – Psilocybin for mental distress in frontline healthcare workers

PHASE 2
Psychedelic Effects On Brain3

Kernel Flow - Neuroimaging Technology

PHASE 1
Major Depressive Disorder

CYB003 - Deuterated Psilocybin Analog

PRECLINICAL
Alcohol Use Disorder

CYB003 - Deuterated Psilocybin Analog

PRECLINICAL
Anxiety Disorders

CYB004-Deuterated Dimethyltryptamine (DMT)

PRECLINICAL
Neuroinflammation

CYB005-Phenethylamine Derivative

PRECLINICAL

Q1 2022

Completed CYB003
preclinical studies

CYB003 Scientific
Advice meeting with
UK MHRA

Initiated EMBARK
Phase 2 IIT study

Initiated Kernel Flow
feasibility study

Q2 2022

Submitted CYB003 IND filing for Phase 1/2a MDD trial

Announced Preclinical data for CYB004 vs. DMT 

Accelerated CYB004 into Phase 1 development through acquisition

Late Q2: preclinical data expected for CYB005

Nominate CYB005 as partnering candidate

Q3 2022

Mid-2022:
Initiate CYB003 Phase 1/2a MDD study

Continue to progress CYB004-E Phase 1 clinical trial

.

Q4 2022

Potential CYB003 interim data readout

NOTES:
  1. 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.
  2. 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.
  3. Cybin-sponsored Phase 1 feasibility study evaluating Kernel’s Flow Technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics.

Our Psychedelic Molecules & Program Overview

CYB003: Deuterated Psilocybin Analog

Our lead investigational molecule, CYB003, is derived from psilocybin, which is part of a family of molecules called indolamines that includes more common neurotransmitters, such as 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 designed to achieve less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability for an overall better outcome for patients. CYB003 has the potential to effectively treat major depressive disorder (MDD) and alcohol use disorder (AUD).

Current status: regulatory filing submitted in May 2022 and Phase 1/2a trial initiation expected in mid-2022

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 anxiety disorders.

Current status: Conducting Phase 1 in-human study evaluating 50 healthy volunteers who smoke tobacco

CYB005: Discovery-Phase Phenethylamine Derivative

CYB005 is a discovery-phase phenethylamine derivative with the potential to effectively treat neuroinflammation and psychiatric conditions.

Current status: In preclinical development

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 Work

Our 3 Pillar Strategy

1
 

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.

2
 

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.

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.

3
 

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)
SUBLINGUAL FILM
1MG
3MG
5MG
7MG
8
8
8
8
CAPS
25MG
8
TOTAL PATIENTS
40
PHASE IIB
Randomized Double Blind Placebo Controlled Safety & Efficacy Study
SELECTED DOSE PY SUBLINGUAL FILM
80
PLACEBO
40
TOTAL PATIENTS
120

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.