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Cybin Inc
Symbol CYBN
Shares Issued 164,640,303
Close 2022-04-20 C$ 0.93
Market Cap C$ 153,115,482
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Cybin contracts Clinilabs for CYB003 phase 1/2a trial

2022-04-21 10:10 ET - News Release

Mr. Doug Drysdale reports

CYBIN PARTNERS WITH CLINILABS DRUG DEVELOPMENT CORPORATION FOR PHASE 1/2A TRIAL EVALUATING CYB003 FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDE

Cybin Inc. has partnered with Clinilabs Drug Development Corp., a global, full-service contract research organization with deep expertise in central nervous system drug development, to carry out the company's phase 1/2a clinical trial of CYB003, a proprietary deuterated psilocybin analogue. CYB003 will be the first psilocybin analogue to be evaluated in phase 1/2a development for the treatment of major depressive disorder (MDD).

"We are delighted to partner with the Clinilabs team as we progress this important program toward a first-in-human phase 1/2a trial. Clinilabs brings a unique combination of scientific and operational experience and deep expertise in clinical research across a range of psychiatric, neurological and substance use disorders," said Doug Drysdale, chief executive officer of Cybin. "Clinilabs is ideally suited to help us accelerate the regulatory pathway for this promising treatment candidate and, ultimately, to effectively treat those suffering with MDD."

In multispecies preclinical studies, CYB003 demonstrated significant advantages over classic psilocybin, including less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability for an overall better outcome for patients. Cybin recently announced the completion of its IND-enabling (investigational new drug) in vivo preclinical studies of CYB003. Data from these studies support the advancement toward an investigational new drug filing with the U.S. Food and Drug Administration (FDA) for the phase 1/2a clinical trial. Cybin intends to submit an IND to the FDA in the second quarter of 2022 and expects to initiate the phase 1/2a trial in mid-2022.

"Approximately one-third to one-half of people with MDD demonstrate an inadequate response to antidepressant drug treatment. Treatment options for these patients currently are limited to dose escalation, switching or combining antidepressants, or augmentation therapy, often with unsatisfactory results," said Dr. Gary Zammit, president and chief executive officer of Clinilabs. "It is a privilege to be working with Cybin, an innovator in the development of novel psychedelic therapeutics, to conduct its first-in-human clinical trial of CYB003. This trial is designed to assess the efficacy and safety of CYB003 in patients with MDD and is among the first to evaluate a standardized psychedelic treatment regimen in this patient population."

About CYB003

CYB003 is derived from psilocybin, which is part of a family of molecules called indolamines, which 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 analogue that has the potential to effectively treat major depressive disorder and alcohol use disorder.

About Cybin Inc.

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, 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, 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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