Cybin receives European OK for Embrace depression trial

Mr. Gabriel Fahel reports CYBIN RECEIVES EUROPEAN APPROVAL FOR EMBRACE, A MULTINATIONAL PHASE 3 STUDY EVALUATING CYB003 FOR THE ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER Cybin Inc.'s 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 U.K. 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, 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 milligrams (mg), CYB003 eight mg or inactive placebo. Each study arm will evaluate two doses, administered three weeks apart. The primary end point 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 United States, and patient rollover into Extend is continuing. 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. About Cybin Inc. Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental health care by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions. With promising proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long-lasting results. The company is currently developing CYB003, a proprietary deuterated psilocin analog, in phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule, in a phase 2 study for generalized anxiety disorder. The company also has a research pipeline of investigational, 5-HT-receptor focused compounds. Founded in 2019, Cybin is operational in Canada, the U.S., the United Kingdom, the Netherlands and Ireland. We seek Safe Harbor.