What is the EMBRACE trial?

The EMBRACE trial is a Phase III clinical study being conducted by Cybin to evaluate the efficacy of its investigational drug CYB003, a deuterated psilocin analogue, for the adjunctive treatment of major depressive disorder.

Where will the EMBRACE trial take place?

The EMBRACE trial will be conducted at approximately 60 clinical sites across Europe, the United States, and Australia.

How many subjects will the EMBRACE trial enroll?

The EMBRACE trial aims to enroll 330 subjects with moderate to severe major depressive disorder who have had an inadequate response to antidepressants.

Home / Health / Cybin Expands Reach of Pivotal Depression Trial to Ireland, Poland, and Greece

Cybin Expands Reach of Pivotal Depression Trial to Ireland, Poland, and Greece

8 Aug

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Summary

Cybin secures approval for Phase III EMBRACE trial of CYB003 for major depressive disorder
Trial to enroll 330 subjects across 60 sites in Europe, US, and Australia
Broader PARADIGM program plans to enroll 550 subjects across 3 trials

Cybin Expands Reach of Pivotal Depression Trial to Ireland, Poland, and Greece

In a significant development, Cybin has secured approval from the Irish Medicines Board to initiate the multinational Phase III EMBRACE study of its investigational drug CYB003 for the adjunctive treatment of major depressive disorder (MDD). This approval follows the recent green light from the UK's Medical and Healthcare products Regulatory Agency to begin the study in the United Kingdom.

The EMBRACE trial aims to enroll 330 subjects with moderate to severe MDD who have had an inadequate response to antidepressants but are on a consistent medication dose. Participants will be randomly assigned to receive either 16mg or 8mg of CYB003, a deuterated psilocin analogue, or a placebo, with two doses given three weeks apart. The primary goal is to measure the change in depression symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) at six weeks after the first dose.

The EMBRACE study is part of Cybin's broader PARADIGM program, which plans to enroll a total of 550 subjects across three trials, including the APPROACH and EXTEND studies. Those from the APPROACH and EMBRACE trials will be eligible to join the long-term EXTEND trial after their initial 12-week placebo-controlled treatment period.

Cybin CEO Doug Drysdale expressed his enthusiasm for the expanded reach of this critical research, stating that the rise in mental health disorders knows no borders, and the company is committed to an international research base to develop new and more effective treatments for MDD patients everywhere.

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