Cybin Inc. (NEO: CYBN | NYSE: CYBN), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today announced that it has partnered with Clinilabs Drug Development Corporation, 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 analog. CYB003 will be the first psilocybin analog to be evaluated in Phase 1/2a development for the treatment of major depressive disorder.
“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,” “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.”
Doug Drysdale, Chief Executive Officer of Cybin.
In multi-species 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 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 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,” “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.”
Dr. Gary Zammit, President & CEO of Clinilabs
About CYB003
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 that has the potential to effectively treat major depressive disorder and alcohol use disorder.
About Clinilabs Drug Development Corporation
Clinilabs Drug Development Corporation is the only global, full-service contract research organization (CRO) focused exclusively on central nervous system (“CNS”) drug development. With deep expertise in CNS, we are committed to the development of medicines that treat a range of psychiatric, neurological and substance use disorders, as well as rare and ultra-rare CNS diseases. Clinilabs partners with pharmaceutical and biotechnology companies to deliver a complete, first-in-human to Phase 3 spectrum of high quality, timely, and cost-effective clinical drug development services, with the shared goal of speeding new CNS medicines to market. We are process-driven yet structured to be nimble, providing personalized service that meets the needs of customers and projects of all sizes. Clinilabs has conducted more than 675 CNS clinical trials in our 21-year history and played a pivotal role in the approval of 19 new therapies across 10 CNS indications to help transform the lives of patients worldwide.
About Cybin
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.