05:29:56 EDT Thu 28 Mar 2024
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or Name
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Cybin Inc
Symbol CYBN
Shares Issued 166,120,171
Close 2022-08-16 C$ 1.01
Market Cap C$ 167,781,373
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Cybin receives DEA licence for phase 1/2a CYB003 trial

2022-08-17 09:08 ET - News Release

Mr. Doug Drysdale reports

CYBIN AND CLINILABS GRANTED SCHEDULE I DEA LICENSE FOR CYB003 PHASE 1/2A FIRST-IN-HUMAN CLINICAL TRIAL

The United States Drug Enforcement Agency (DEA) has granted a schedule 1 licence to support the first-in-human phase 1/2a clinical trial of Cybin Inc.'s CYB003, a proprietary deuterated psilocybin analog that is being developed for the treatment of major depressive disorder (MDD).

"Obtaining a DEA license for our phase 1/2a trial is the final step clearing the way to begin dosing participants in our first-in-human study of CYB003. Our rigorous recruitment and enrolment process is well under way, and we are excited to commence dosing of our first cohort of participants," said Doug Drysdale, chief executive officer of Cybin.

The DEA licence is a federal requirement for any investigators who intend to study, produce, analyze or otherwise work with schedule 1 controlled substances.

About the CYB003 phase 1/2a trial

The phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating people with moderate to severe MDD. Participants will receive two administrations (placebo/active and active/active) and a response/remission will be assessed at week 3 (after first dose) and at week 6 (after second dose). Importantly, participants in the trial that are currently being treated with antidepressants will be allowed to remain on their antidepressant medication.

Using the Montgomery-Asberg depression rating scale, the trial will assess rapid onset of antidepressant effect on the day of dosing. The study will also evaluate the incremental benefit of a second dose of CYB003 when administered at week 3 and will provide important PK and safety data to determine a clinical path forward. An optional period of assessment will help determine the durability of treatment effect out to 12 weeks. The detailed phase 1/2a study protocol is available under the identifier No: NCT05385783.

This research study is recruiting individuals between the ages of 21 and 55 who have been diagnosed with MDD and who are currently taking an antidepressant medication that is not working to their satisfaction. Participation includes 11 outpatient visits and two two-day inpatient stays. Participants who are located within reasonable travel distance to the Clinilabs Eatontown, N.J., clinical research unit, may prescreen for study entry by telephone at 212-994-4567.

About CYB003

CYB003 is a deuterated analog of psilocybin which is part of a family of molecules called indolamines that include 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, psilocin can easily activate the serotonin 5-HT2A receptor.

CYB003 is designed to potentially address the challenges and limitations of oral psilocybin. Based on preclinical data, CYB003 achieved less variability in plasma levels, faster onset of action and shorter duration of effect. The company believes CYB003 has the potential to reduce time and resource burden on patients, providers and payers, and, possibly, to improve scalability and accessibility of treatment.

About Cybin Inc.

Cybin is a leading ethical biopharmaceutical company which works with a network of world-class partners and internationally recognized scientists; it is on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The company is focused on progressing psychedelics to therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

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