Helus Pharma’s HLP004 Phase 2 Trial Shows 67% Responder Rate
Helus Pharma’s Phase 2 signal-detection study of HLP004 enrolled 36 adults with moderate-to-severe GAD, administering two intramuscular doses (20 mg or 2 mg) over three weeks alongside standard antidepressants. The 20 mg arm showed a 10.4-point mean HAM-A reduction at six weeks, with 67% responders and 39% remission at six months.
1. Trial Design and Methodology
Helus Pharma conducted a signal-detection Phase 2 study in 36 adults with moderate-to-severe generalized anxiety disorder who remained symptomatic despite standard SSRI treatment. Participants were randomized 2:1 to receive intramuscular HLP004 at 20 mg or 2 mg twice over three weeks, with follow-up assessments through 12 weeks and an extended one-year safety monitoring period.
2. Topline Efficacy Results
The high-dose cohort experienced a mean 10.4-point reduction on the Hamilton Anxiety Rating Scale at six weeks, achieving statistical significance and clinically meaningful improvement. At six months, 67% of the overall treated population were classified as responders and 39% reached remission, while the 2 mg arm recorded a 30% response and remission rate at six weeks.
3. Clinical Implications and Next Steps
These encouraging Phase 2 results support advancement of HLP004 into larger controlled trials, potentially positioning Helus Pharma for a pivotal study in 2026. Positive durability and early remission metrics could attract partnership interest and bolster the company’s valuation ahead of regulatory interactions and further dose-optimization efforts.