Cybin talks HLP004 phase 2 study results

Executive Summary

• Cybin Inc. (operating as Helus Pharma) announced top-line results from a Phase 2 signal detection study for HLP004, an investigational intramuscular deuterated serotonergic agonist, in patients with moderate to severe generalized anxiety disorder (GAD) who remained symptomatic despite standard-of-care antidepressant therapy.
• The study demonstrated clinically meaningful efficacy, with patients receiving 20 mg of HLP004 achieving a mean reduction of 10.4 points in the Hamilton Anxiety Rating Scale (HAM-A) from baseline at six weeks (p < 0.0001).
• The treatment showed a favorable tolerability profile with no drug-related serious adverse events or suicidality-related safety signals, supporting the continued development of HLP004.

Key Details

• Study Design: Phase 2 signal detection study involving 36 patients randomized two-to-one (active-to-placebo) to receive either HLP004 20 mg or 2 mg.
• Dosing Regimen: Two intramuscular doses administered three weeks apart.
• Patient Population: Adults with moderate to severe GAD who remained symptomatic despite continuing standard-of-care (SoC) antidepressant therapy (including SSRIs).
• Baseline Metrics: Average baseline HAM-A score of 22; General Anxiety Disorder-7 (GAD-7) score ≥ 10 at screening.
• Primary Efficacy Result: Patients receiving 20 mg HLP004 adjunctive to SoC therapy achieved a mean reduction of 10.4 points in HAM-A from baseline at six weeks (p < 0.0001).
• Long-term Efficacy (6 Months):
  • Pooled study population showed 67% responders and 39% remitters.
  • 20-milligram arm: 59% response rate and 32% remission rate at week 6.
  • 2-milligram arm: 30% response rate and 30% remission rate at week 6.
• Safety Profile: Favorable tolerability with no drug-related serious adverse events or suicidality-related safety signals.
• Operational Feasibility: Short in-clinic treatment experience with acute drug effects lasting approximately 90 minutes and discharge readiness within approximately three hours.
• Future Outlook: CEO Michael Cola noted excitement regarding the potential for HLP004 and announced plans to release data on HLP003 (targeted at major depressive disorder) in the fourth quarter of 2026.

Notable Quotes

• "These phase 2 results support the continued development of HLP004, and I am encouraged by the magnitude of improvement observed over standard-of-care treatments, together with the rapid onset and short in-clinic treatment experience, for this patient population with limited options." — Dr. Andrew Cutler, Clinical Professor of Psychiatry at SUNY Upstate Medical University and Senior Adviser to Helus Pharma.
• "Patients living with generalized anxiety disorder remain significantly underserved, with many continuing to struggle despite currently available treatments. We are encouraged by these data and the potential for HLP004 to bring hope to GAD patients." — Michael Cola, Chief Executive Officer of Helus Pharma.