– EMBRACE, the second Phase 3 study within the PARADIGM program, expects to enroll 330 participants at approximately 60 clinical sites across the United States, Europe and Australia and will commence imminently –
– PARADIGMTM comprises two 12-week randomized, double-blind, placebo-controlled studies (APPROACH® and EMBRACE®) and a long-term extension study (EXTEND), with anticipated combined enrollment of approximately 550 participants –
– Dosing is currently underway in the first pivotal study, APPROACH, and patient rollover has begun into EXTEND –
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 it has received approval from the UK Medical and Healthcare Products Regulatory Agency (“MHRA”) to commence EMBRACE, the second pivotal study in PARADIGM, the Company’s Phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analog. The Company previously received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (“FDA”) for CYB003 for the adjunctive treatment of Major Depressive Disorder (“MDD”).
“MHRA approval to initiate the EMBRACE component of our PARADIGM program in the UK marks an important step forward as we advance our lead program, CYB003, through the regulatory process,” said Doug Drysdale, Chief Executive Officer of Cybin. “The Agency’s decision serves as strong validation of both the quality of our data and the urgent need to develop new and effective therapeutics to treat depression. With expected enrollment of 330 participants suffering from moderate to severe MDD, the EMBRACE study aims to generate critical late-stage data that, ultimately, may lead to transforming the standard of care for patients in need.”
“There are encouraging signs of clinical and commercial success across this sector, along with increasing political and regulatory support. Health expert Dr. Martin Makary, Commissioner of the U.S Food and Drug Administration, has publicly recognized the potential value of these innovative therapeutics and has stated his intention to prioritize and expedite the review process. The commercial success of esketamine is also a positive signal for the entire sector. In the second quarter of 2025, esketamine sales totaled $366 million in the U.S. and $414 million worldwide, representing 61.1% growth year over year in the U.S., and an annual run rate of roughly $1.7 billion.1 These positive factors contribute to the credibility and opportunity of the work we are doing at Cybin,” concluded Drysdale.
EMBRACE™ Study Design:
- EMBRACE will enroll 330 patients suffering from 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.
EMBRACE is the second Phase 3 randomized, double-blind clinical trial in the PARADIGM program, and is expected to enroll participants at approximately 60 clinical sites across the U.S., Europe, and Australia. The first Phase 3 trial, APPROACH, is taking place at approximately 45 clinical sites across the U.S. 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.
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