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 and robust treatment benefits, with 100% of participants responding to treatment and 71% achieving remission at 12 months following just two 16 mg doses.
The study's findings, presented by Cybin's Chief Medical Officer, Dr. Amir Inamdar, validate the dosing regimen and confirm the durable effects of CYB003, offering sustained relief for MDD patients. The data also supports the FDA's Breakthrough Therapy Designation for CYB003, potentially expediting its review pathway.
Long-Term Efficacy Data
The Phase 2 study assessed the long-term efficacy of CYB003 in patients with MDD. Key findings include:
- A mean change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score of approximately 23 points at 12 months after two 16 mg doses (n=7).
- 100% response rate among participants receiving two 16 mg doses, defined as a ≥50% reduction in MADRS score.
- 71% remission rate among participants receiving two 16 mg doses, defined as a MADRS total score ≤10.
For the 12 mg dosing arm, 60% of participants receiving two doses were responders, and 50% were in remission.
Safety and Tolerability
CYB003 continues to demonstrate an excellent safety profile. No new adverse events, including reports of suicidality, were reported during the 12-month follow-up period.
Implications for MDD Treatment
These results suggest that CYB003 has the potential to revolutionize the current standard of care for MDD. Current treatments often require chronic, daily administration and may only provide symptomatic relief. CYB003 offers the possibility of infrequent, long-lasting therapeutic effects, potentially improving accessibility to treatment and reducing the burden on both patients and treatment centers.
"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," said Doug Drysdale, CEO of Cybin. "We are quite possibly witnessing a watershed moment in mental health care treatment paradigms and practices."
Ongoing Development
Cybin has initiated a Phase 3 PARADIGM pivotal program to further evaluate the efficacy and safety of CYB003 in a larger MDD patient population. The company also anticipates reporting Phase 2 topline results for CYB004, a deuterated dimethyltryptamine program for generalized anxiety disorder, in the first quarter of 2025.
