Helus Pharma’s HLP004 Cuts Anxiety Scores 10.4 Points, Delivers 67% Response
Helus Pharma’s Phase 2 trial of HLP004 adjunctive to standard care yielded a mean 10.4-point HAM-A reduction (p<0.0001) at six weeks in 36 moderate-to-severe GAD patients. Study showed 67% responders and 39% remitters at six months, acute 90-minute effects with three-hour discharge, and no serious adverse events.
1. Topline Phase 2 Study Results
Helus Pharma announced topline data from a 36-patient Phase 2 signal detection study evaluating HLP004 20 mg and 2 mg adjunctive to standard of care in moderate-to-severe generalized anxiety disorder patients who remained symptomatic on existing therapy.
2. Significant Efficacy Findings
At six weeks, the 20 mg arm achieved a mean 10.4-point reduction on the Hamilton Anxiety Rating Scale (p<0.0001), with the pooled population delivering 67% responders and 39% remitters at six months.
3. Treatment Profile and Tolerability
HLP004 produced acute intramuscular effects lasting approximately 90 minutes and allowed discharge within three hours; the treatment was well tolerated with no drug-related serious adverse events recorded.
4. Market Potential and Unmet Need
With no approved adjunctive GAD pharmacology in two decades and over 20 million affected US adults, HLP004’s rapid onset and durable response position Helus Pharma to address a projected $4.26 billion GAD market by 2033.