Cybin Inc. (CYBN) is making significant strides in its clinical programs targeting major depressive disorder (MDD) and generalized anxiety disorder (GAD). The company is preparing to initiate a Phase 3 study for CYB003 in MDD and anticipates key data readouts for both CYB003 and CYB004 in the coming months. These advancements underscore Cybin's commitment to developing innovative treatments for challenging mental health conditions.
CYB003: Pivotal Phase 3 Study Imminent
Cybin's lead program, CYB003, a deuterated psilocin formulation, has received Breakthrough Therapy Designation from the FDA for the adjunctive treatment of MDD. This designation highlights the potential for CYB003 to offer substantial improvements over existing treatments. Following a productive Type B meeting with the FDA, Cybin is poised to commence its Phase 3 pivotal trial in MDD, utilizing 30 high-quality clinical sites across the United States and Europe. The trial design incorporates elements to mitigate methodological issues such as functional unblinding.
Data from the completed Phase 2 study of CYB003 in MDD demonstrated rapid and robust improvements in depressive symptoms after a single dose. Notably, a 75% remission rate was observed in the 16mg dose group after two doses. The company expects to report 12-month Phase 2 efficacy data in early Q4 2024, which will provide further insights into the durability of CYB003's effects.
The Phase 2 results showed:
- A 13.75 point difference in MADRS score reduction between CYB003 (12mg and 16mg pooled) and placebo at 3 weeks (p<0.0001).
- Response rates exceeding 75% and remission rates up to 80% (12 mg) after the second dose.
- Sustained efficacy at 4 months after two doses, with a mean 22-point reduction in MADRS scores from baseline and remission rates of 60% (12 mg) and 75% (16 mg).
- An excellent safety and tolerability profile, with all reported adverse events being mild to moderate.
CYB004: Advancing Towards Phase 2 Topline Results
CYB004, a deuterated N,N-dimethyltryptamine (DMT) program, is being developed for the treatment of GAD. This formulation is designed for intramuscular (IM) administration, aiming to optimize delivery and produce acute effects lasting approximately 90 minutes. Dosing is currently underway in a Phase 2 study involving participants with moderate to severe GAD. Cybin anticipates reporting topline safety and efficacy results by the end of 2024 or early Q1 2025.
The Phase 2 program for CYB004 includes:
- A randomized, double-blind study in 36 participants with moderate to severe GAD (GAD-7 score ≥10).
- Two IM doses administered three weeks apart, compared to two low-dose controls.
- The primary endpoint is the change in Hamilton Anxiety Rating Scale (HAM-A) score from baseline at 6 weeks following the second dose.
- Secondary endpoints include the Montgomery-Asberg Depression Rating Scale depression assessment, safety assessments, MEQ30 (psychedelic experience assessment), and EQ-5D-5L (quality of life assessment).
- Participants will be followed up for three months initially, with additional assessments up to one year.
Strengthening the R&D Team
Cybin has recently appointed Dr. Atul R. Mahableshwarkar as Senior Vice President, Clinical Development, to lead the CYB003 program. Dr. Mahableshwarkar brings extensive experience in drug development and psychiatry. Additionally, Dr. Tom Macek has joined as Senior Vice President, Clinical Development, to lead the CYB004 program, contributing decades of pharmaceutical industry experience.
Doug Drysdale, CEO of Cybin, stated, "We are making rapid advancements in our two lead clinical programs… We have made significant progress in preparing for our upcoming Phase 3 programs and have appointed two experienced drug development experts… As we evolve into a Phase 3 Company, we are well positioned among the top tier in our sector and believe that we have the potential to deliver innovative, next-generation approaches to address these challenging mental health disorders."
