Cybin Completes FDA Meeting, Plans CYB003 Phase 3 for Major Depression
Cybin Inc., a clinical-stage neuropsychiatry company, is making strides in revolutionizing mental healthcare by developing innovative next-generation treatment options. Recently, the company held a Type B Initial Breakthrough Therapy Meeting with the U.S. Food and Drug Administration (FDA) in Washington, D.C. This meeting has paved the way for Cybin to initiate its Phase 3 pivotal trial of CYB003 for the adjunctive treatment of major depressive disorder (MDD) by late summer 2024.
Doug Drysdale, CEO of Cybin, expressed optimism following the meeting, confirming plans to commence the Phase 3 program as anticipated. With 30 clinical sites chosen across the United States and Europe, Cybin is preparing to launch the next phase of clinical development, building on the positive outcomes observed so far. During the Phase 2 study, CYB003 demonstrated a robust and sustained effect, with 75% of patients in remission from depression four months after receiving two 16mg doses. The company expects to report 12-month efficacy data from this study by the fourth quarter of this year.
To address concerns raised in recent industry discussions surrounding functional unblinding, Cybin has planned several measures to mitigate this risk in its pivotal study program. These measures include:
- A three-arm study design with high dose, mid-dose, and placebo arms. This approach ensures patients will not know whether they received the therapeutic high dose or the sub-therapeutic mid-dose, thereby reducing unblinding and expectancy bias.
- Utilization of remote, independent, blinded raters who will be unaware of the dose or the participant's dosing experience.
- Firewalling the reporting of effects during the dosing session to keep the study team blinded.
- Recruiting participants who are largely psychedelic-naïve to minimize expectancy bias.
- Assessing long-term efficacy data points up to one year to outlast potential expectancy effects.
Additionally, the study will incorporate manual and real-time artificial intelligence screening of monitoring sessions to ensure fidelity and patient safety.
Cybin also announced changes to its Governance and Nominating Committee, and Compensation Committee. The Governance and Nominating Committee will now consist of Eric Hoskins (Chair), Mark Lawson, and Theresa Firestone, while the Compensation Committee will include Grant Froese (Chair), Mark Lawson, and Theresa Firestone.
Cybin is dedicated to creating safe and effective next-generation therapeutics to meet the substantial unmet needs of those suffering from mental health conditions. The company’s efforts are supported by a network of world-class partners and internationally recognized scientists. These collaborations aim to advance proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches, and treatment regimens.
Cybin's current projects include developing CYB003, a proprietary deuterated psilocybin analog program for treating major depressive disorder, and CYB004, a proprietary dDMT molecule for generalized anxiety disorder. Their research pipeline also features various investigational psychedelic-based compounds.
Founded in 2019 and headquartered in Canada, Cybin operates in Canada, the United States, the United Kingdom, the Netherlands, and Ireland. The company is committed to transforming mental healthcare through innovative solutions and groundbreaking research.
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