FAQ: Cybin's EMBRACE Phase 3 Study Approval in Australia for CYB003
Summary
What is the main announcement in this content?
Cybin Inc. has received approval in Australia to conduct the EMBRACE study, which is the second pivotal trial in its Phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analog.
Why is this approval significant for Cybin?
This approval allows Cybin to initiate the EMBRACE Phase 3 study in Australia, advancing their development of CYB003 as a potential adjunctive treatment for major depressive disorder and supporting their mission to revolutionize mental healthcare.
How did Cybin receive approval for this study in Australia?
Approval was granted through Australia’s Clinical Trial Notification scheme, with clearance from multiple Ethics Committees of the Australian Therapeutics Goods Administration and Research Governance Offices.
What is CYB003 and what condition is it being developed to treat?
CYB003 is Cybin’s proprietary deuterated psilocin analog currently in Phase 3 studies for the adjunctive treatment of major depressive disorder.
What other treatments is Cybin developing besides CYB003?
Cybin is also developing CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in Phase 2 study for generalized anxiety disorder, and has a research pipeline of investigational 5-HT-receptor focused compounds.
Where is Cybin operational besides Australia?
Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands, and Ireland.
What makes Cybin’s approach to mental health treatment different?
Cybin is working to introduce intermittent treatments that provide long-lasting results, aiming to change the mental health treatment landscape with next-generation options for unmet needs.
Where can investors find the latest news and updates about Cybin?
The latest news and updates relating to CYBN are available in the company’s newsroom at https://ibn.fm/CYBN.
What is the PARADIGM program mentioned in the content?
PARADIGM is Cybin’s Phase 3 multinational program evaluating CYB003, with EMBRACE being the second pivotal trial within this program.
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