Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) has now concluded the preliminary series of steps required before administering doses of its proprietary psilocybin analogue to patients.
On Tuesday, the biotechnology company happily announced that it had dosed its first two participants in the Phase 1/2a trial of CYB003 for treating Major Depressive Disorder (MDD).
The news follows successful trial approval from the U.S. Food and Drug Administration (FDA) in June and the U.S. Drug Enforcement Administration (DEA) earlier this month.
Cybin is pleased to announce that the first two participants have been dosed in our Phase 1/2a trial evaluating CYB003 for the treatment of MDD.
This clinical milestone marks the initiation of the first-ever novel psilocybin analog to enter clinical development. pic.twitter.com/K97gubU8kv
— CybinInc (@CybinInc) August 30, 2022
Read more: Cybin receives Schedule I DEA license for CYB003 trial
Read more: Cybin receives FDA approval for new in-human clinical trial
Based on pre-clinical data, the novel psilocybin analogue developed by the company has characteristics which render it superior to the standard mushroom variation, according to Cybin.
For clinical usage, those traits are potentially quite significant. A more rapid onset time, double the brain penetration capability and a significantly reduced duration for users are examples of those alleged superior characteristics that will now be put to the test going forward with more in-human data emerging.
Photo via Cybin
“To commence dosing in our first-in-human Phase 1/2a trial is a tremendous milestone for Cybin, especially having reached the clinic within just 18 months. Our goal continues to focus on becoming a leader in creating the best psychedelic therapies for patients and today we have moved one step closer,” said Doug Drysdale, CEO of Cybin.
“Through our rigorous preclinical work and ongoing clinical development of CYB003, we believe we have the potential to unlock the powerful benefits of psilocybin for the treatment of MDD without its well-known limitations,” added Drysdale.
“The high level of participant interest in our study serves to validate the significant unmet need for alternative and better treatment options to improve mental health conditions. We expect that this Phase 1/2a trial will provide valuable insights and data. These findings will be critical in establishing a safe and efficacious treatment profile for CYB003 so we can continue to progress our mission to help revolutionize the treatment landscape for people suffering from depression,” he concluded.
