Psilocybin for MDD clinical trial begins enrollment

Clinilabs Drug Development Corp. announced enrollment has begun in a phase 1/2a clinical trial for the use of CYB003, a novel psilocybin analog that will be evaluated for the treatment of major depressive disorder.

CYB003 is being developed by Cybin Inc., a biopharmaceutical company, which announced it received investigational new drug clearance from the FDA at the end of June. The drug is the first novel psilocybin analog to enter clinical development, according to a press release from Clinilabs.

“Clinilabs is honored to be working with Cybin, an innovator in the development of novel psychedelic therapeutics, to conduct its first-in-human clinical trial of CYB003,” Jeanine Falinski, Clinilabs vice president of strategy and development, said the release. “We are excited by the potential of these therapeutics and hope that the future is life-changing for individuals suffering from mental illness. We are encouraged by the interest from potential research participants who have already come forward prior to today.”

The phase 1/2a trial is a randomized, double-blind, placebo-controlled study among those with major depressive disorder. Participants will receive two administrations of CYB003, and response will be assessed at week 3 (after the initial dose) and at week 6 (after the second dose).

Participants will be assessed using the Montgomery-Asberg Depression Rating Scale. Those included in the trial will also have the option for assessment 12 weeks post-baseline.

The trial is currently recruiting individuals aged 21 to 55 years who have been diagnosed with major depressive disorder and who are taking either a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor that is not working to their satisfaction. Participation includes 11 outpatient visits and two 2-day inpatient stays.

“Successful patient recruitment and a proper clinical environment are integral components of this trial,” Cybin CEO Doug Drysdale said in the release.