EMBRACE, the second study within the Phase 3 PARADIGM program, will enroll 330 participants at approximately 60 clinical sites across the United States, Europe, the United Kingdom, and Australia –
European CTA approval to initiate the EMBRACE study in Ireland, Poland, and Greece has been received
Recently received Medicines and Healthcare products Regulatory Agency (“MHRA”) approval to commence EMBRACE in the United Kingdom
Data from completed Phase 2 MDD study showed that 71% of participants were in remission and 100% of participants responded to treatment at 12 months after just two 16 mg doses of CYB003
Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to advancing mental healthcare by developing new and innovative next-generation treatment options, today announced that its Clinical Trial Application (“CTA”) has been approved by the Irish Medicines Board, acting as the reference Member state, to initiate the EMBRACE™ study in Ireland, Poland, and Greece. EMBRACE is the second pivotal study in PARADIGM®, the Company’s Phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analog. The Company also recently announced approval from the Medical and Healthcare products Regulatory Agency (“MHRA”) to commence EMBRACE in the United Kingdom.
CYB003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (“FDA”) for the adjunctive treatment of Major Depressive Disorder (“MDD”).
“Securing European approval to commence the EMBRACE component of PARADIGM – especially on the heels of the recent UK MHRA approval – validates the quality of our Phase 3 clinical development program and reaffirms the strength of our results to date,” said Doug Drysdale, Chief Executive Officer of Cybin. “We appreciate the trust placed in us by the European Regulatory Agencies and are eager to leverage Europe’s well-established clinical trial infrastructure. The EMBRACE study aims to enroll 330 participants who live with moderate to severe MDD and whose symptoms are inadequately controlled with antidepressant treatments. With this additional approval, which enables us to enroll participants in Ireland, Poland, and Greece, we are pleased to expand the reach for this critical research. The rise in mental health disorders knows no borders, and we are committed to an international research base to develop new and more effective treatments for MDD patients everywhere.”
EMBRACE™ Study Design:
- EMBRACE will enroll 330 patients with moderate to severe MDD (MADRS≥24) who are on a stable dose of antidepressant medication but are responding inadequately. Study participants will be randomized 1:1:1 to receive either CYB003 16 mg, CYB003 8 mg, or inactive placebo. Each study arm will evaluate two doses, administered three weeks apart.
- The primary endpoint will be change in depressive symptoms as measured by change in MADRS from baseline at six weeks after the first dose.
The Phase 3 PARADIGM™ program is expected to enroll a total of 550 participants across three studies: two 12-week randomized, double-blind, placebo-controlled studies, APPROACH™ and EMBRACE, and a long-term extension study, EXTEND. The first Phase 3 trial, APPROACH, is currently dosing and is taking place at approximately 45 clinical sites across the U.S, and patient rollover into EXTEND is ongoing. The second Phase 3 trial, EMBRACE, is expected to enroll participants at approximately 60 clinical sites across the U.S., Europe, and Australia. Participants from APPROACH and EMBRACE will have the opportunity to roll over into EXTEND after completing the 12-week, double-blind, placebo-controlled treatment periods.
