Cybin Inc. (NEO: CYBN) (NYSE:CYBN), a biopharmaceutical company focused on psychedelics for mental health, announced Tuesday that the first two participants have been dosed in its Phase 1/2a trial evaluating CYB003 for the treatment of the major depressive disorder (MDD). 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. These preclinical data demonstrated that CYB003 has the potential to reduce the time and resource burden on patients, providers, and payers, and possibly improve scalability and accessibility of treatment,” Cybin reported in a press release.
A 'tremendous milestone for 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,” said Doug Drysdale, CEO of Cybin.
“The high level of participant interest in our study validates the unmet need for alternative and better treatment options to improve mental health conditions. he continued.
CYB003 And Oral Psilocybin
According to Cybin, in multi-species preclinical studies comparing CYB003 with oral psilocybin, data demonstrated:
- a well-tolerated profile following several doses in multiple species that supports repeat dosing;
- a similar in vitro and in vivo pharmacology profile when compared to psilocin, the active naturally occurring psychedelic agent in psilocybin;
- a 50% reduction in variability;
- a 50% dose reduction;
- a 50% shorter time to onset; and,
- nearly double the brain penetration indicating the potential for less variable treatment response.
Details About The Trial
The Phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating people with moderate to severe MDD. The 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 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). Importantly, participants in the trial that are currently being treated with antidepressants will be allowed to remain on their antidepressant medication.
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 administered at Week 3 and will provide important 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.
Photo by Hal Gatewood on Unsplash.
