Therapy Areas: Central Nervous System
Cybin Submits IND Application to FDA for its Phase 1/2a First-in-Human Trial of CYB003 for the Treatment of Major Depressive Disorder
31 May 2022 - - Canada-based biopharmaceutical company Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) which is focused on progressing "Psychedelics to Therapeutics," has submitted an Investigational New Drug application to the US Food and Drug Administration for its Phase 1/2a first-in-human clinical trial evaluating CYB003, a proprietary deuterated psilocybin analog, for the treatment of major depressive disorder, the company said.

The Phase 1/2a trial is a randomized, double blind, placebo-controlled study evaluating people with moderate to severe MDD.

Subjects will receive two administrations (placebo/active and active/active) and a response/remission will be assessed at Week 3 (after single dose) and at Week 6 (after receiving a second dose).

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 benefit of more than one administration and will provide pharmacokinetic and safety data.

The trial design will allow for people to continue their treatment with selective serotonin reuptake inhibitors.

An optional open-label follow-up study (up to 12 weeks) will allow an assessment of durability of treatment effects.

The company has engaged Clinilabs Drug Development Corp., a global, full-service contract research organization with deep expertise in central nervous system drug development, to carry out the Phase 1/2a clinical trial of CYB003.

The detailed Phase 1/2a study protocol is available at under the Identifier number: NCT05385783.

CYB003 is derived from 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 a deuterated psilocybin analog designed to achieve less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability. CYB003 has the potential to effectively treat MDD and alcohol use disorder.

Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, United Kingdom 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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