Cybin completes FDA Type B initial breakthrough meeting D

Cybin announced that it held a Type B Initial Breakthrough Therapy Meeting with the U.S. Food and Drug Administration late last week in Washington, D.C. The company plans to initiate its Phase 3 pivotal trial of CYB003 for the adjunctive treatment of MDD in late summer of 2024. “Following our productive Type B meeting, we continue to expect to commence our Phase 3 pivotal program in late summer,” said Doug Drysdale, Chief Executive Officer of Cybin. “Having selected 30 clinical sites across the United States and Europe, we are eager to initiate this next phase of clinical development and to build on the positive impact of CYB003 to date. In our Phase 2 study, CYB003 showed a robust and sustained effect, with 75% of patients in remission from depression four months after two 16mg doses. We expect to report 12-month efficacy data from the Phase 2 study in the fourth quarter of this year. We look forward to ongoing engagement with the FDA as we advance our path to bringing new, improved treatment options to patients and providers.” Further to recent industry discussions around the subject of functional unblinding, the Company plans to implement multiple measures to attempt to mitigate the risk of functional unblinding in its pivotal study program.