FAQ: Cybin Inc.'s EU Approval for EMBRACE Phase 3 MDD Study

What is the EMBRACE Phase 3 study about?

The EMBRACE Phase 3 study is part of Cybin’s PARADIGM program, evaluating CYB003, a deuterated psilocin analog, for the treatment of Major Depressive Disorder (MDD) in participants with inadequately controlled symptoms.

Why is the EU approval for the EMBRACE study significant?

EU approval allows Cybin to initiate the EMBRACE study in Ireland, Poland, and Greece, expanding the research and potential treatment options for MDD patients in these regions.

How many participants will be enrolled in the EMBRACE study?

The study will enroll 330 participants across multiple international sites to assess two dose levels of CYB003 against a placebo.

What is CYB003?

CYB003 is Cybin’s proprietary deuterated psilocin analog, granted Breakthrough Therapy Designation by the FDA for the adjunctive treatment of Major Depressive Disorder.

Where will the EMBRACE study take place?

The study will be conducted in Ireland, Poland, and Greece, among other international sites.

Who is conducting the EMBRACE study?

Cybin Inc., a clinical-stage neuropsychiatry company, is conducting the EMBRACE study as part of its PARADIGM program.

What are the goals of Cybin Inc.?

Cybin aims to revolutionize mental healthcare by developing innovative, next-generation treatment options for mental health conditions, focusing on intermittent treatments that provide long-lasting results.

How can I learn more about Cybin Inc. and its studies?

For more information, visit Cybin’s website at www.cybin.com or follow them on social media platforms like X, LinkedIn, YouTube, and Instagram.

What other treatments is Cybin developing?

Besides CYB003 for MDD, Cybin is developing CYB004 for generalized anxiety disorder and has a research pipeline of investigational, 5-HT-receptor focused compounds.

Where is Cybin Inc. operational?

Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands, and Ireland.