Cybin Inc. has announced a delay in the initiation of its Phase 3 clinical trial for CYB003, a novel treatment for Major Depressive Disorder (MDD). The company had previously aimed to commence the study in late summer 2024, but that goal has not been met as the end of September approaches. Despite the delay, Cybin has completed the selection of 30 clinical sites across the United States and Europe for the trial.
Phase 3 Trial Preparations
Cybin reported in August that it anticipated spending approximately $13 million to initiate the Phase 3 study of CYB003 in MDD during the summer of 2024, with $2.3 million already spent in the second quarter. An additional $2.9 million was spent during the twelve months ending March 31, 2024, leaving an estimated $7.9 million remaining for the trial's initiation.
The company held a Type B Initial Breakthrough Therapy Meeting with the U.S. Food and Drug Administration (FDA) in August to prepare for the pivotal CYB003 program in MDD. According to Cybin, the Phase 3 trial design incorporates elements to address critical methodological issues, such as functional unblinding, considered important for drugs in this class. However, no patients have been enrolled in the study to date.
Promising Phase 2 Data
Cybin's Phase 2 MDD study of CYB003 demonstrated rapid improvements in depression symptoms with a single dose. Durable effects were observed four months after two doses, with a 75% remission rate in the 16mg dose group. The company anticipates reporting 12-month Phase 2 efficacy data in early Q4 2024, which is expected to provide further insights into CYB003’s potential for long-lasting relief for MDD patients.
Reverse Share Split
Cybin recently completed a reverse share split to reduce the number of outstanding shares and increase the value per share. The consolidation ratio was set at one share for every 38 shares. As a result, the number of shares was reduced from 759,692,495 to approximately 19,991,907.
