Helus Pharma HLP004 Achieves 10.4-Point HAM-A Reduction, 67% Response Rate
Helus Pharma’s Phase 2 study showed that 20 mg HLP004 adjunctive therapy achieved a mean 10.4-point reduction in HAM-A scores at six weeks, with 67% responders and 39% remitters at six months across dosing arms. The trial reported a 90-minute acute effect window and no drug-related serious adverse events.
1. Signal Detection Study Outcomes
Helus Pharma enrolled 36 adults with moderate-to-severe generalized anxiety disorder who remained symptomatic on standard therapies in a 2-to-1 randomization to 20 mg or 2 mg HLP004 intramuscular doses. At six weeks, the 20 mg group achieved a 10.4-point mean HAM-A reduction from baseline, with 59% responders and 32% remitters; the 2 mg arm saw 30% response and remission rates. Pooled data at six months showed 67% responders and 39% remitters across both dosing arms.
2. Safety and Clinical Feasibility
Acute drug effects peaked in approximately 90 minutes, enabling patient discharge within about three hours and fitting existing interventional psychiatry clinic workflows. No drug-related serious adverse events or suicidality-related safety signals were observed in either dosing cohort, indicating a favorable tolerability profile.
3. Next Data and Development Plans
Helus Pharma plans to release Phase 2 signal detection data for HLP003, targeting major depressive disorder, in the fourth quarter of 2026. These upcoming results will guide dose selection and pivotal trial design for HLP003’s development in treatment-resistant depression.