Cybin Advances CYB003 into Phase 3 for Major Depressive Disorder
Key Insights
Cybin (search) Inc. has initiated its Phase 3 PARADIGM program to evaluate CYB003 for the adjunctive treatment of Major Depressive Disorder (search) (MDD (search)).
The PARADIGM program includes two 12-week studies (APPROACH and EMBRACE) and a long-term extension study (EXTEND), aiming for 550 patients.
Phase 2 data showed significant improvements in depressive symptoms with CYB003, supporting the progression to Phase 3 trials.
Cybin (search) Inc. (CYBN) has commenced its Phase 3 PARADIGM program, a multinational effort to assess the efficacy and safety of CYB003 as an adjunctive treatment for major depressive disorder (search) (MDD (search)). This pivotal program, which includes the APPROACH and EMBRACE studies, aims to enroll approximately 550 patients across more than 40 clinical sites in the United States and Europe.
The PARADIGM program is comprised of two 12-week, randomized, double-blind, placebo-controlled studies (APPROACH and EMBRACE) and a long-term extension study (EXTEND). The APPROACH study has already been initiated and will enroll 220 participants. Topline efficacy data from the CYB004 Phase 2 study in generalized anxiety disorder (search) are expected in the first half of 2025, with the EXTEND and EMBRACE studies of CYB003 slated to begin around mid-year 2025.
Promising Phase 2 Results
Data from the Phase 2 study of CYB003 demonstrated notable improvements in reducing depressive symptoms, which encouraged the advancement to Phase 3. Specifically, 100% of participants receiving two doses of 16 mg of CYB003 were responders, and 71% achieved remission. The mean change from baseline in MADRS (Montgomery-Åsberg Depression Rating Scale) was approximately -23 points after two doses of 16 mg.
Financial Position
Cybin (search) reported a solid financial position, with cash reserves totaling C$136.3 million as of December 31, 2024. While the company experienced a net loss of C$10.5 million for the quarter ended December 31, 2024, this was an improvement compared to a net loss of C$30.3 million in the same period last year. The company also launched a new at-the-market equity program to potentially raise up to US$100 million.
Management Optimism
"As we advance our lead clinical programs, CYB003 and CYB004, our focus in 2025 remains on continued successful execution," said Doug Drysdale, CEO of Cybin (search). "With the initiation of PARADIGM, our multinational pivotal Phase 3 program evaluating CYB003 for the adjunctive treatment of MDD (search), we look forward to a rigorous investigation and to confirming the data from our Phase 2 study in a larger patient population."
CYB004 and CYB005
Cybin (search)'s pipeline also includes CYB004, currently in a Phase 2 proof-of-concept study for generalized anxiety disorder (search) (GAD (search)), with topline safety and efficacy results expected in the first half of 2025. Additionally, Cybin announced the grant of its first U.S. Composition of Matter patent in support of its CYB005 phenethylamines program, which is being explored for various central nervous system disorders.