Cybin Inc. announced that it has received approval from the UK Medical and Healthcare Products Regulatory Agency (MHRA) to commence EMBRACE. This marks the initiation of the second pivotal study within PARADIGM, Cybin’s Phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analog.
The EMBRACE study is expected to enroll 330 participants at approximately 60 clinical sites across the United States, Europe, and Australia. This expansion into the UK is a significant step forward in advancing CYB003 through the regulatory process for the adjunctive treatment of Major Depressive Disorder (MDD).
Dosing is currently underway in the first pivotal study, APPROACH, and patient rollover has begun into EXTEND, the long-term extension study. The MHRA's decision serves as strong validation of both the quality of Cybin's data and the urgent need for new and effective therapeutics to treat depression.
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