Cybin Inc. (NYSE American: CYBN) (Cboe CA: CYBN) (“Cybin” or the “Company”), a clinical-stage neuropsychiatry company focused on advancing mental healthcare through innovative, next-generation treatments, recently shared key clinical accomplishments and outlined its upcoming milestones.
“We’re making significant progress in our two lead programs—CYB003, our proprietary deuterated psilocin program for Major Depressive Disorder (MDD), and CYB004, our deuterated dimethyltryptamine program for Generalized Anxiety Disorder (GAD). We’re gearing up for Phase 3 trials and have strengthened our team by appointing two seasoned drug development experts: Dr. Atul R. Mahableshwarkar to lead the CYB003 program and Dr. Tom Macek for CYB004. These advancements position us as leaders in our sector, with the potential to deliver transformative solutions for mental health disorders,” said Doug Drysdale, CEO of Cybin.
CYB003: A Breakthrough Therapy for MDD
CYB003, the company’s leading program for MDD, has received FDA Breakthrough Therapy Designation (BTD), signaling its potential for substantial improvements over current treatments. This status helps expedite its path toward commercialization.
In August 2024, Cybin held a successful Type B Breakthrough Therapy meeting with the FDA, preparing for the upcoming Phase 3 pivotal trial. The study will be conducted across 30 clinical sites in the U.S. and Europe and will address methodological challenges like functional unblinding, critical for this class of drugs.
Results from a completed Phase 2 trial showed promising outcomes: rapid symptom improvements after a single dose, and sustained benefits up to four months after two doses, with remission rates of 75% in the 16mg group. Additional 12-month efficacy data from this Phase 2 study are expected in early Q4 2024.
Positive Phase 2 Results for CYB003 in MDD:
- Significant symptom improvements with a 13.75-point difference in MADRS scores between CYB003 and placebo after 3 weeks.
- Over 75% response and up to 80% remission rates after a second dose.
- Sustained efficacy 4 months post-dosing with up to 75% remission.
- Excellent safety profile with mild to moderate adverse events.
CYB004: A Novel DMT-Based Therapy for GAD
CYB004 is being developed for GAD as an intermittent treatment using an intramuscular (IM) formulation, with effects lasting around 90 minutes. A Phase 2 study is currently underway, evaluating the drug’s efficacy, onset of action, and long-term effects in participants with moderate to severe GAD. Topline safety and efficacy results are anticipated by year-end 2024 or early 2025.
CYB004 Phase 2 Study Highlights:
- Randomized, double-blind trial involving 36 participants with moderate to severe GAD.
- Two IM doses administered three weeks apart, with comparison to low-dose controls.
- Primary outcome: change in Hamilton Anxiety Rating Scale (HAM-A) scores 6 weeks after the second dose.
- Secondary outcomes include depression and quality of life assessments.
- Participants will be followed for up to a year for long-term data.
Strengthening the Leadership Team
To support these clinical programs, Cybin has appointed two key leaders:
- Dr. Atul R. Mahableshwarkar, M.D., DLFAPA, Senior Vice President, Clinical Development, will oversee the CYB003 program. A board-certified psychiatrist with extensive drug development experience, Dr. Mahableshwarkar has led multiple successful drug approval processes.
- Dr. Tom Macek, Pharm.D., Ph.D., Senior Vice President, Clinical Development, will lead the CYB004 program. With decades of experience across various treatment modalities, Dr. Macek has played pivotal roles in advancing numerous drug approvals throughout his career.
