Cybin (CYBN) Sets Stage for Phase 3 Trial for Major Depressive Disorder After Successful FDA Meeting

The PRISM Psychedelics Index company Cybin Inc. (CYBN), a clinical-stage neuropsychiatry company, recently held a Type B Initial Breakthrough Therapy Meeting with the FDA in Washington, D.C. The company is on track to initiate its Phase 3 pivotal trial of CYB003 for the adjunctive treatment of major depressive disorder (MDD) by late summer 2024.

To address concerns about functional unblinding in clinical studies, Cybin plans to implement several strategies in its trial including:

• A three-arm design with high dose, mid-dose, and placebo groups where patients remain unaware if they received the high therapeutic dose or the subtherapeutic mid-dose.
• Use of remote, independent, and blinded raters who have no knowledge of dosing or participants’ experience.
• Firewalls to prevent the study team from being influenced by the effects reported during dosing sessions, ensuring continued blinding.
• Recruitment of predominantly psychedelic-naïve participants to further minimize expectancy bias.
• Collection of long-term efficacy data up to one year to counter any expectancy effects.

Doug Drysdale, CEO of Cybin said, “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.”

Additionally, Cybin has restructured its Governance and Nominating Committee and its Compensation Committee to now consist entirely of independent directors.

In separate news, Cybin addressed concerns regarding the FDA Rejecting MDMA Therapy for PTSD. At Canaccord Genuity’s 2024 Growth Conference, management noted events that led to a Complete Response Letter for Lykos’ MDMA-assisted therapy for post-traumatic stress disorder (PTSD) were specific to that company, and do not have an impact on CYBN’s ongoing programs.