Cybin Reports Positive Phase 2 Data for CYB003

Cybin Inc. (NYSE American: CYBN; Cboe CA: CYBN), a clinical-stage neuropsychiatry company, has announced encouraging 12-month efficacy data from its Phase 2 study of CYB003, a proprietary deuterated psilocin analog in development for the potential adjunctive treatment of major depressive disorder (MDD). Notably, CYB003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA), providing an expedited review pathway that underscores its potential impact on mental health treatment.

Sustained Efficacy with Intermittent Dosing

The Phase 2 study evaluated the effects of administering two doses of CYB003, three weeks apart. Participants receiving two 16 mg doses demonstrated remarkable and sustained improvements:

• Mean Change in MADRS Score: Approximately 23-point reduction from baseline.
• Response Rate: 100% of participants were responders (≥50% reduction in MADRS score).
• Remission Rate: 71% achieved remission (MADRS total score ≤10) at the 12-month follow-up.

In the 12 mg dosing group, participants also showed significant benefits:

• Mean Change in MADRS Score: Approximately 18-point reduction.
• Response Rate: 60% were responders.
• Remission Rate: 50% achieved remission at 12 months.

These findings suggest that CYB003’s effects are not only robust but also durable over a prolonged period, which is particularly noteworthy given the chronic nature of MDD.

Favorable Safety Profile

CYB003 was well-tolerated, with no new adverse events reported during the 12-month follow-up period. Importantly, there were no incidents of suicidality among participants, highlighting the compound’s safety in a population at risk for such outcomes.

Potential Shift in MDD Treatment Paradigms

Doug Drysdale, Chief Executive Officer of Cybin, emphasized the significance of these results: “We are quite possibly witnessing a watershed moment in mental healthcare treatment paradigms.” He pointed out that up to two-thirds of MDD patients do not achieve remission with first-line antidepressants, which often require daily dosing and may only offer symptomatic relief.

CYB003’s intermittent dosing regimen—two doses per treatment cycle—could offer a more patient-friendly and efficient alternative. Compared to existing intermittent treatments like esketamine, electroconvulsive therapy (ECT), and transcranial magnetic stimulation (TMS), which can require up to 36 outpatient visits, CYB003 has the potential to reduce the treatment burden on patients and healthcare systems alike.

Advancing to Phase 3 and Pipeline Expansion

Building on these positive results, Cybin has initiated its Phase 3 PARADIGM™ pivotal program to evaluate CYB003’s efficacy and safety in a larger MDD population. Additionally, the company anticipates reporting Phase 2 topline results for CYB004—its proprietary deuterated dimethyltryptamine (DMT) program for generalized anxiety disorder—in the first quarter of 2025.

Future Perspective

The sustained high response and remission rates observed with CYB003 are impressive and suggest a potential breakthrough in MDD treatment. The ability to achieve such outcomes with just two doses over 12 months could significantly differentiate CYB003 from current therapies that require chronic administration. Moreover, the excellent safety profile enhances its appeal as a viable treatment option.

However, while these results are promising, it is important to consider that Phase 2 studies involve smaller patient populations. The upcoming Phase 3 trials will be critical in confirming these findings and assessing the drug’s efficacy and safety on a larger scale.