Cybin Inc. has announced Phase 2 interim results for CYB003 – its proprietary deuterated psilocybin analogue – which it says has demonstrated positive results with a rapid reduction in symptoms of major depressive disorder (MDD).
CYB003 demonstarted a rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo, Cybin has stated.
Chief Executive Officer of Cybin, Doug Drysdale, commented: “The overwhelmingly positive interim results for the 12mg dose of CYB003 are extremely encouraging for patients and providers.
“The efficacy demonstrated at that dosage showed an unprecedented reduction in depressive symptoms compared to currently available treatments.
“With these encouraging results in hand, we look forward to sharing the full complement of topline data later this quarter, and 12-week durability data in the first quarter of 2024. Our planning continues as we prepare for a larger international, multisite Phase 3 trial in early 2024 to further evaluate the safety and efficacy of CYB003 in people suffering from MDD.”
The Phase 2 clinical trial evaluated efficacy using the MADRS scale. Its primary efficacy endpoint was a reduction in depression symptoms at week three after a single administration. The company has stated that, to date, dosing has been completed in all dose cohorts up to 16mg, with a favorable safety and tolerability profile and no treatment-related serious adverse events observed.
“These positive interim safety and efficacy results support progressing to pivotal studies. We plan to request an end of Phase 2 meeting with the FDA in early 2024 to align on Phase 3 trial design, and we are commencing dosing with a capsule formulation of CYB003 in the bioequivalence cohort and further manufacturing of GMP materials that will be dose flexible, patient friendly and commercially scalable,” stated Drysdale.
“This is an exciting time – not only for Cybin, but for the entire psychedelics sector – as we now have interim results showing a significant improvement in depressive symptoms with a single dose, moving us ever closer to delivering on our mission to improve the treatment landscape across the spectrum of mental health disorders.”
Cybin’s Chief Medical Officer, Amir Inamdar, added: “Mental health disorders affect almost 1 billion people worldwide. Comorbid MDD occurs widely in medical and psychiatric disorders, including anxiety disorders and post-traumatic stress disorder. These interim results, together with emerging data from a number of academic studies, suggest that CYB003 may have therapeutic efficacy in range of mental health conditions.”
