Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) has made some substantial progress pertinent to an upcoming clinical trial assessing a proprietary psilocybin analogue (a new psychoactive drug) intended to treat Major Depressive Disorder (MDD).
On Wednesday, the biopharmaceutical company announced that it had received a Schedule I license from the U.S. Drug Enforcement Administration (DEA) permitting the first in-human Phase 1/2a clinical trial for CYB003.
Cybin received approval for the trial from the Food and Drug Administration (FDA) at the end of June, and the company says that the new DEA license is a federal requirement for any researchers intending to engage in studies with Schedule I controlled substances.
"Obtaining a DEA license for our Phase 1/2a trial is the final step clearing the way to begin dosing participants in our first-in-human study of CYB003. We are excited to commence dosing of our first cohort of participants,”
-CEO Doug Drysdale
Read more: https://t.co/AB1ova2ghi pic.twitter.com/y95sd7IZaJ
— CybinInc (@CybinInc) August 17, 2022
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The Canadian biopharmaceutical company is currently recruiting people between 21-55 years of age who suffer from MDD and aren’t finding that antidepressants are providing adequate relief for their mental health condition.
“This Phase 1/2a trial represents the first time that a psilocybin analog will be evaluated for the treatment of MDD and is the key next step forward with our ultimate goal of providing a new and effective treatment for people suffering with mental health conditions,” said Doug Drysdale, CEO at Cybin.
The new research endeavour will be conducted in partnership with Clinilabs Drug Development Corporation, a full-service contract research organization (CRO) that Cybin says has outstanding expertise in the field of central nervous system drug development.
