Cybin has reported positive topline data from the Phase II clinical trial of its deuterated psilocybin analogue, CYB003, to potentially treat major depressive disorder (MDD).
The trial analysed the safety and efficacy of CYB003.
According to the trial findings, a quick and clinically significant decline in depression symptoms was reported following treatment with a single dose of the therapy.
Furthermore, a significant incremental benefit was observed after the administration of a second dose.
The trial met the primary efficacy endpoint with a mean -14 point difference in the Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline between a 12mg dose of CYB003 compared to placebo at three weeks.
In the trial, 79% of participants responded to treatment while 79% were in remission from depression following treatment with two doses of the analogue at six weeks.
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The 12mg and 16mg doses demonstrated a favourable safety and tolerability profile without any drug-associated serious adverse events reported.
Furthermore, CYB003 offered improvement versus currently approved antidepressants and data reported following the use of other psychedelics.
The company noted that the latest trial findings support the advancement of CYB003 to Phase III development.
Cybin CEO Doug Drysdale said: “We are delighted to share that CYB003 achieved the primary efficacy endpoint in this study and showed rapid and statistically significant improvements in depression symptoms after a single dose, with a clear incremental benefit of a second dose, resulting in four out of five patients in remission from their depression at six weeks.
“This is an impressive finding and follows on from the unprecedented interim results we announced earlier this month. Importantly, the strength of the data supports progression to a Phase III study of CYB003 for the treatment of MDD.”
The company plans to submit the latest data to the US Food and Drug Administration and anticipates holding an end-of-Phase II meeting in the first quarter of next year.
Additional 12-week durability findings from this Phase II trial of CYB003 and subject recruitment for the Phase III study are anticipated around the same time.