Cybin Inc. has announced positive 12-month efficacy data from its Phase 2 study of CYB003, a deuterated psilocin analog, for the adjunctive treatment of major depressive disorder (MDD). The results demonstrate sustained benefits with a high response rate and remission rate after just two doses.
The Phase 2 study showed that 100% of participants were responsive to treatment, and 71% were in remission at 12 months following two 16 mg doses of CYB003. Participants also experienced a ~23-point reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) score compared to baseline at 12 months.
Durable Efficacy and Safety
Amir Inamdar, Chief Medical Officer of Cybin, noted, "We are highly encouraged that our approach to treating MDD patients with two 16 mg doses of CYB003, three weeks apart, has demonstrated consistent, robust and sustained treatment benefits through to the 12-month follow up... These findings validate our dosing regimen and confirm that CYB003’s effects are highly durable and offer sustained relief."
The study also highlighted the safety and tolerability of CYB003, reinforcing its potential as a viable treatment option for MDD. Cybin has initiated the Phase 3 PARADIGM pivotal program to further evaluate the efficacy and safety of CYB003 in a larger MDD population.
Potential to Revolutionize MDD Treatment
Doug Drysdale, CEO of Cybin, stated, "Our Phase 2 study results are remarkable and validate both our intermittent dosing regimen, as well as CYB003’s potential to revolutionize the current standard of care in MDD... With CYB003, we have the opportunity to pivot away from the chronic, daily treatments that often only offer symptomatic relief, and move towards more patient-friendly infrequent, long-lasting therapeutics for MDD patients who do not achieve remission with existing treatments."
Study Details
The Phase 2 study included participants who completed a 12-month follow-up. For the 16 mg dose, seven participants received two active doses, and one received a single active dose after an initial placebo. The mean change from baseline in MADRS was ~23 points after two doses (n=7), with 100% response and 71% remission rates.
For the 12 mg dose, ten participants received two active doses, and three received a single active dose after an initial placebo. The mean change from baseline in MADRS was ~18 points after two doses (n=10), with 60% response and 50% remission rates.
Next Steps
Cybin anticipates reporting Phase 2 topline results for CYB004, a deuterated dimethyltryptamine program for generalized anxiety disorder, in the first quarter of 2025. The company is committed to progressing CYB003 toward potential regulatory approval and commercialization.
