Helus Pharma Announces Topline Results in Phase 2 Signal Detection Study for HLP004 in Patients with Generalized Anxiety Disorder

Executive Summary

• Helus Pharma reported statistically significant and clinically meaningful improvement in generalized anxiety disorder (GAD) patients treated with HLP004, showing a mean 10.4‑point reduction in HAM‑A scores versus baseline (p < 0.0001).
• At six months, 67% of the pooled study population were responders and 39% achieved remission; response/remission rates were higher in the 20 mg arm (59%/32%).
• The intramuscular treatment demonstrated rapid onset (≈90‑minute effect) with short clinic time (≈3 hours discharge readiness) and was well tolerated, with no drug‑related serious adverse events.

Key Details

• Study Design: Randomized, 2:1 active-to-placebo; 36 patients received HLP004 20 mg or 2 mg intramuscularly, two doses three weeks apart; follow‑up to Week 12 and observational up to one year.
• Baseline Severity: Mean HAM‑A score = 22; GAD‑7 ≥ 10 at screening.
• Efficacy – 20 mg Arm:
• Mean HAM‑A reduction = 10.4 points at six weeks (p < 0.0001).
• Responders = 59%; Remitters = 32% at week 6.
• Efficacy – 2 mg Arm:
• Responders ≈ 30%; Remitters ≈ 30% at week 6.
• Pooled Population (All Doses):
• Responders = 67% at six months.
• Remitters = 39% at six months.
• Safety: No drug‑related serious adverse events or suicidality signals; adverse events were transient.
• Administration Advantages: Acute effects last ~90 minutes; patients ready for discharge within ~3 hours, supporting scalability in interventional psychiatry clinics.
• Forward Outlook: Company plans to release Phase 2 data on HLP003 (major depressive disorder) in Q4 2026 and continue development of HLP004 toward further clinical milestones.

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, SUNY Upstate Medical University & Senior Advisor to Helus Pharma.

“Patients living with generalized anxiety disorder remain significantly underserved… We are encouraged by these data and the potential for HLP004 to bring hope to GAD patients,” – Michael Cola, Chief Executive Officer, Helus Pharma.