Cybin Announces Completion of FDA Type B Initial Breakthrough Therapy Meeting and Plans for CYB003 Phase 3 Program in Major Depressive Disorder

Business Wire
6 min read

In This Article:

- Company expects to initiate Phase 3 pivotal trial in late summer 2024 -

- Phase 3 pivotal study to include 30 clinical sites across the United States and Europe with deep expertise in depression studies -

- Pivotal trial designs incorporate elements to address functional unblinding -

- Company to report 12-month Phase 2 efficacy data for CYB003 in Major Depressive Disorder ("MDD") in Q4 2024 -

TORONTO, August 13, 2024--(BUSINESS WIRE)--Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) ("Cybin" or the "Company"), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today announced that it held a Type B Initial Breakthrough Therapy Meeting with the U.S. Food and Drug Administration ("FDA") 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, as follows:

  • The pivotal study program will include one study with a three-arm design with a high dose, mid-dose, and placebo arm. Patients will not know if they received the therapeutic high dose or the sub therapeutic mid-dose, mitigating the unblinding to an extent and addressing potential expectancy bias;

  • The study will utilize remote, independent, blinded raters who will not have any information on the dose received or the participant’s dosing experience;

  • The reporting of effects during the dosing session will be firewalled to ensure that the study team stays blinded;

  • The studies will recruit participants who are largely psychedelic na?ve to reduce the impact of expectancy bias;

  • The studies will assess long-term efficacy data points up to one year, to outlast any potential expectancy effects.

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