Phase 3 multinational trial set to begin early this year
Cybin Inc. said Jan. 4 its CYB003 psilocybin treatment resulted in a 79% remission rate from depression symptoms within six weeks for Phase 2 trial participants who received two 12-milligram doses of the drug.
The company is set to begin a multinational Phase 3 trial scheduled in early 2024.
The safety and efficacy datasets from the company’s lead clinical programs compare favorably to existing treatments for depression and anxiety disorders, said Cybin CEO Doug Drysdale.
“With each promising dataset, we gain confidence in our ability to revolutionize the treatment of mental health disorders and to give patients and providers hope for longer lasting and improved outcomes,” he said.
The upcoming milestones for the CYB003 program include assessing the durability of efficacy at 12 weeks in the first quarter of 2024, an FDA end-of-Phase 2 meeting in early 2024 and the initiation of the Phase 3 trial in major depressive disorder in early 2024.