Three weeks after announcing the results of its preclinical trials for CYB003, Cybin (NYSE:CYBN) made public a partnership with Clinilabs Drug Development Corporation to take the proprietary drug to its next phase.
Clinilabs is to carry out Cybin’s Phase 1/2a clinical trial of CYB003 for treating Major Depressive Disorder (MDD). According to the company, this will be the first psilocybin analog to be evaluated in a Phase 1/2a trial for this particular disorder.
Doug Drysdale, CEO of Cybin expressed his excitement for the new study: “We are delighted to partner with the Clinilabs team as we progress this important program toward a first-in-human Phase 1/2a trial.”
The company intends to submit an investigational new drug application to the FDA in the second quarter of 2022, with the hopes of initiating the new trial in mid-2022.
“Approximately one-third to one-half of people with MDD demonstrate an inadequate response to antidepressant drug treatment,” explained Gary Zammit, president and CEO of Clinilabs. “Treatment options for these patients currently are limited to dose escalation, switching or combining antidepressants, or augmentation therapy, often with unsatisfactory results.”
Another of Cybin’s second-generation psychedelics that has been on the news lately is the DMT analog CYB004, which showed promise over traditional antidepressants in a recent preclinical study.
