Cybin, a clinical-stage neuropsychiatry company focused on advancing innovative mental health treatments, announced today that its Clinical Trial Application (CTA) has been approved by the Irish Medicines Board—acting as the reference member state—for the initiation of the EMBRACE™ study in Ireland, Poland, and Greece.
This milestone follows recent approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to launch the trial in the United Kingdom.
EMBRACE is the second pivotal study under Cybin’s Phase 3 PARADIGM® program, which evaluates CYB003, a proprietary deuterated psilocin analog, as an adjunctive treatment for Major Depressive Disorder (MDD). CYB003 has already earned Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for this indication.
“Securing European approval for EMBRACE—hot on the heels of the UK MHRA nod—validates our Phase 3 program’s quality and reinforces the strength of our results to date,” said Doug Drysdale, Cybin’s Chief Executive Officer.
“We’re grateful for the trust from European regulators and eager to leverage Europe’s robust clinical trial infrastructure. Mental health disorders spare no borders, and our international research efforts aim to deliver more effective treatments for MDD patients worldwide.”
EMBRACE Study DREAD MOREetails
The EMBRACE trial will enroll 330 adults with moderate to severe MDD (MADRS score ≥24) whose symptoms are inadequately controlled by existing antidepressants.
Participants will be randomized 1:1:1 to receive either 16 mg CYB003, 8 mg CYB003, or a placebo, with two doses administered three weeks apart. The primary endpoint is the change in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to six weeks after the first dose.
The broader PARADIGM program includes three studies: two 12-week randomized, double-blind, placebo-controlled trials (APPROACH™ and EMBRACE) and a long-term extension study (EXTEND).
APPROACH is currently dosing at approximately 45 U.S. sites, with patient rollover into EXTEND underway. EMBRACE is expected to enroll participants across 60 sites in the U.S., Europe, and Australia.
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