Cybin Initiates Phase 3 Trial for CYB003 in Major Depressive Disorder Following Promising Phase 2 Results
Key Insights
Cybin (search) has launched a Phase 3 clinical trial program, PARADIGM, to evaluate CYB003 as an adjunctive treatment for Major Depressive Disorder (search) (MDD).
The Phase 3 program is supported by strategic partnership agreements (SPAs) with clinical sites, starting with Segal Trials (search), to enhance trial efficiency.
Phase 2 data showed that two 16 mg doses of CYB003, administered three weeks apart, led to a 71% remission rate from depression symptoms for 12 months.
Cybin (search) Inc. has commenced its Phase 3 clinical trial program, known as PARADIGM, to investigate CYB003 as an adjunctive treatment for Major Depressive Disorder (search) (MDD). This multinational pivotal trial builds upon the encouraging results from the Phase 2 study, which demonstrated a substantial remission rate among patients treated with CYB003.
The PARADIGM program is designed to assess the efficacy and safety of CYB003 in a larger patient population across multiple sites in the United States and Europe. The company aims to enroll approximately 550 patients across more than 40 clinical sites.
Strategic Partnerships to Enhance Trial Efficiency
To support the Phase 3 program, Cybin (search) has established strategic partnership agreements (SPAs) with leading clinical research sites. The first SPA is with Segal Trials (search), a company with a network of six research sites throughout South Florida and extensive experience in psychiatric, neurological, and psychedelic research.
"Following the release of our remarkable Phase 2 data, which demonstrated that two 16-mg doses of CYB003 administered three weeks apart provided remission from depression symptoms for 12 months for the majority of patients, we are excited that our Phase 3 multinational pivotal program is underway," said Doug Drysdale, Chief Executive Officer of Cybin (search).
The SPAs are intended to facilitate collaboration among sites, cultivate long-term partnerships, enhance efficiency in trial operations, and improve overall site performance. Close cooperation and coordination between site staff and Cybin (search) will ensure quality standards, mitigate potential risks, and enhance efficiency through economies of scale.
Promising Phase 2 Data
The decision to move forward with Phase 3 trials was supported by compelling Phase 2 data. The results indicated that two 16 mg doses of CYB003, administered three weeks apart, resulted in a 71% remission from depression symptoms that lasted for 12 months in the majority of patients.
"We are thrilled to collaborate with Cybin (search) on its innovative Site Partnership Program. This partnership will accelerate learning at new sites around the country, enabling more research and could ultimately expedite the approval process for CYB003," said Bonnie Segal, President of Segal Trials (search).
About CYB003
CYB003 is Cybin (search)'s proprietary deuterated psilocin program, currently in Phase 3 development for the adjunctive treatment of major depressive disorder (search). Cybin is also developing CYB004, a proprietary deuterated N, N-dimethyltryptamine program in a Phase 2 study for generalized anxiety disorder (search).