The UK Medical and Healthcare products Regulatory Agency (MHRA) has granted approval for Cybin to initiate the randomised EMBRACE study to assess CYB003 for the adjunctive treatment of major depressive disorder (MDD).
EMBRACE is the second pivotal trial in the company’s Phase III multinational programme, PARADIGM.
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The double-blind EMBRACE trial will enrol 330 subjects with moderate to severe MDD who are not adequately responding to antidepressants but are on stable doses.
Subjects will be randomised and given either 16mg or 8mg of CYB003 or a placebo. Each trial arm will assess two doses given three weeks apart.
The change in depressive symptoms six weeks after the initial dose is the trial’s primary endpoint.
The trial is set to take place across approximately 60 clinical sites in Australia, Europe, and the US.
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By GlobalDataAPPROACH is the first trial in PARADIGM and is underway at nearly 45 US sites.
Participants from both APPROACH and EMBRACE will have the option to continue into the EXTEND study following the completion of the double-blind, 12-week, placebo-controlled treatment period.
Cybin CEO Doug Drysdale said: “MHRA approval to initiate the EMBRACE component of our PARADIGM programme in the UK marks an important step forward as we advance our lead programme, CYB003, through the regulatory process.
“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 enrolment 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.”
The US Food and Drug Administration (FDA) had previously granted breakthrough therapy designation to the deuterated psilocin analogue, CYB003, for MDD.
Cybin is also developing a deuterated N, N-dimethyltryptamine molecule, CYB004, which is currently in a Phase II trial for generalised anxiety disorder.
In 2023, Cybin reported encouraging topline data from the Phase II trial of CYB003 to potentially treat MDD.
