DEA grants Schedule I license for psilocybin treatment, MDD clinical trial to begin

Biopharmaceutical company Cybin Inc. and its partner Clinilabs Drug Development Corp. announced they have been granted a Schedule I license to support a clinical trial for a psychedelic-based treatment to treat major depressive disorder.

Cybin and Clinilabs will collaborate on a phase 1/2a study for CYB003, a proprietary deuterated psilocybin analog designed to address challenges and limitations of oral psilocybin, according to a press release from Cybin.

The license from the U.S. Drug Enforcement Administration is a federal requirement for any investigators who intend to study, produce, analyze or otherwise work with Schedule I controlled substances, according to the release.

“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,” Cybin CEO Doug Drysdale said in the release. “Our rigorous recruitment and enrollment process is well underway, and we are excited to commence dosing of our first cohort of participants.”

The pending clinical trial is expected to be a randomized, double-blind, placebo-controlled study that will evaluate patients aged 21 to 55 years with moderate to severe MDD who are prescribed medication that is not working to their satisfaction. Participation in the study will include 11 outpatient visits and two 2-day inpatient stays, where enrollees will receive two administrations (placebo/active and active/active). Response and remission will be assessed at week 3 (after first dose) and at week 6 (after second dose). Participants in the trial who are being treated with antidepressants will be allowed to remain on their antidepressant medication, according to the release.

Using the Montgomery-Asberg Depression Rating Scale, the trial intends to assess rapid onset of antidepressant effect on the day of dosing. The study will also evaluate the incremental benefit of a second dose of CYB003 when administered at week 3 and will provide important pharmacokinetic and safety data to determine a clinical path forward, the company said. An optional period of assessment will help determine the durability of treatment effect out to 12 weeks.