BREAKING: Cybin And Clinilabs Receive DEA License For First-In-Human Clinical Trial Of Psilocybin To Treat Depression

Cybin Inc. CYBN CYBN and Clinilabs Drug Development Corporation (Clinilabs) announced that the U.S. Drug Enforcement Agency (DEA) has granted a Schedule I license to support the first-in-human Phase 1/2a clinical trial of CYB003, a proprietary deuterated psilocybin analog being developed for the treatment of the major depressive disorder (MDD).

"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. Our rigorous recruitment and enrollment process is well underway, and we are excited to commence dosing of our first cohort of participants,” said Doug Drysdale, CEO of Cybin in a press release procured by Benzinga.

“The DEA license is a federal requirement for any investigators who intend to study, produce, analyze, or otherwise work with Schedule I controlled substances,” Cybin, a biopharmaceutical company focused on psychedelics, explained in the release.

Details Of The Study

The Phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating people with moderate to severe MDD.

Participants will receive two administrations (placebo/active and active/active) and a response/remission will be assessed at Week 3 (after the first dose) and at Week 6 (after the second dose).

Using the Montgomery-Asberg Depression Rating Scale, the trial will assess the rapid onset of antidepressant effect on the day of dosing. The study will also evaluate the incremental benefit of the second dose of CYB003 when administered at Week 3 and will provide important PK and safety data to determine a clinical path forward.

An optional period of assessment will help determine the durability of the treatment effect out to 12 weeks. The detailed Phase 1/2a study protocol is available at clinicaltrials.gov under the Identifier number: NCT05385783.

Who Will Participate In The Trials?

Cybin announced that participants in the trial that are currently being treated with antidepressants will be allowed to remain on their antidepressant medication.

This research study is recruiting individuals between the ages of 21 and 55 who have been diagnosed with MDD and who are currently taking an antidepressant medication that is not working to their satisfaction.

Participation includes 11 outpatient visits and two 2-day inpatient stays. Participants who are located within reasonable travel distance to the Clinilabs Eatontown, New Jersey clinical research unit, may pre-screen for study entry at www.depressionpsychedelicstudy.com

What is CYB003?

CYB003 is a deuterated analog of psilocybin, which is part of a family of molecules called indoleamines that include more common neurotransmitters, such as serotonin. Psilocybin is dephosphorylated to form its metabolite psilocin, which can cross the blood-brain barrier. Given its structural similarity to serotonin, psilocin can easily activate the serotonin 5-HT2A receptor. CYB003 is designed to potentially address the challenges and limitations of oral psilocybin. Based on preclinical data, CYB003 achieved less variability in plasma levels, faster onset of action, and shorter duration of effect.

Cybin’s team believes CYB003 has the potential to reduce the time and resource burden on patients, providers, and payers and possibly improve the scalability and accessibility of treatment.

Clinilabs Drug Development Corporation

Clinilabs Drug Development Corporation is the only global, full-service contract research organization focused exclusively on central nervous system drug development. The company focuses on the development of medicines that treat a range of psychiatric, neurological and substance use disorders, as well as ultra-rare diseases. Clinilabs partners with pharmaceutical and biotechnology companies to deliver high-quality, timely and cost-effective clinical drug development services, to speed new medicines to market.

Photo by Terry Vlisidis on Unsplash.