Cybin has partnered with Clinilabs to carry out its Phase 1/2a clinical trial of CYB003, a proprietary deuterated psilocybin analogue.
CYB003 will be the first psilocybin analog to be evaluated in Phase 1/2a development for the treatment of major depressive disorder (MDD).
Cybin CEO, Doug Drysdale, commented: “We are delighted to partner with the Clinilabs team as we progress this important programme 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.”
In multi-species preclinical studies, CYB003 has 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 which support the advancement toward an investigational new drug filing with the US Food and Drug Administration for the Phase 1/2a clinical trial. Cybin intends to submit an IND in the second quarter of 2022 and expects to initiate the Phase 1/2a trial in mid-2022.
President and CEO of Clinilabs, Dr Gary Zammit, commented: “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.”
