Cybin (CYBN) said Thursday the Irish Medicines Board has approved the company's clinical trial application to start the Embrace trial in Ireland, Poland and Greece to treat major depressive disorder or MDD.

The company will enroll 330 participants with moderate to severe MDD in the Embrace trial, which is the second study in Paradigm, its phase 3 multinational program to evaluate deuterated psilocin analog CYB003, the company added.

Cybin said it has recently received the Medical and Healthcare products Regulatory Agency's approval to initiate the Embrace trial in the UK, adding that CYB003 has received the US Food and Drug Administration's breakthrough therapy designation to treat MDD.

The neuropsychiatry company's phase 3 Paradigm program is anticipated to admit a total of 550 patients across three trials, Cybin said, adding that it is currently dosing patients in Approach, its first phase 3 trial, while the Embrace trial is expected to enroll patients at about 60 clinical sites across the US, Europe and Australia.

The company's shares were up more than 1% in recent Thursday trading.

Price: 7.48, Change: +0.02, Percent Change: +0.27