Cybin has secured approval for its clinical trial application (CTA) from the Irish Medicines Board, allowing the company to initiate the multinational Phase III EMBRACE study of CYB003 for the adjunctive treatment of major depressive disorder (MDD).

The study evaluating this deuterated psilocin analogue will take place in Poland, Greece, and Ireland.

It is the second pivotal trial within the PARADIGM programme. This follows the recent approval from the UK's Medical and Healthcare products Regulatory Agency (MHRA) to begin the study in the UK.

The EMBRACE trial aims to enrol 330 subjects with moderate to severe MDD who have had an inadequate response to antidepressants but are on a consistent antidepressant medication dose.

Subjects will be randomly assigned and administered either 16mg or 8mg of CYB003 or a placebo, with two doses given three weeks apart.

Change in symptoms related to depression measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at six weeks after the first dose is the primary goal of the trial.

The broader PARADIGM programme plans to enrol 550 subjects across three trials, including the APPROACH and EMBRACE trials, as well as a long-term extension trial named EXTEND.

EMBRACE is set to recruit subjects at approximately 60 clinical sites across Europe, the US, and Australia.

Those from APPROACH and EMBRACE will be eligible to join EXTEND after their initial 12-week placebo-controlled treatment period.

Cybin CEO Doug Drysdale said: “With this additional approval, which enables us to enrol participants in Ireland, Poland, and Greece, we are pleased to expand the reach for this critical research.

“The rise in mental health disorders knows no borders, and we are committed to an international research base to develop new and more effective treatments for MDD patients everywhere.”

In 2023, the company dosed the last subject in Part B of its three-part CYB004-E Phase I trial of CYB004 in healthy volunteers.