Helus Pharma's HLP004 Shows 10.4-Point HAM-A Reduction, 67% Response Rate
Patients receiving 20 mg HLP004 adjunctive to standard therapy showed a mean 10.4-point HAM-A reduction at six weeks and yielded 67% responders and 39% remitters at six months. Acute effects lasted roughly 90 minutes with patient discharge readiness in three hours, and no drug-related serious adverse events were observed.
1. Phase 2 Signal Detection Results
Helus Pharma reported that patients randomized to 20 mg HLP004 adjunctive to standard-of-care therapy achieved a mean 10.4-point reduction in HAM-A scores at six weeks. The pooled population reached a 67% response rate and 39% remission at six months, while the 2 mg arm showed a 30% response and remission rate at week six.
2. Study Design and Patient Population
The double-blind study randomized 36 adults with moderate-to-severe generalized anxiety disorder, all remaining symptomatic despite ongoing antidepressant or anxiolytic therapy, in a 2:1 ratio to receive either 20 mg or 2 mg HLP004 intramuscularly across two doses three weeks apart. Patients were followed through week 12 with observational follow-up extending to one year.
3. Safety and Tolerability Profile
Acute drug effects lasted approximately 90 minutes with typical clinic discharge readiness within three hours, aligning with existing interventional psychiatry workflows. No drug-related serious adverse events or suicidality-related safety signals were reported, indicating a favorable tolerability profile.
4. Next Steps and HLP003 Timeline
Helus Pharma plans to release Phase 2 data on HLP003 for major depressive disorder in the fourth quarter of 2026, leveraging its broad intellectual property portfolio. The company will evaluate these results to inform pivotal trial design and regulatory strategy for both HLP004 and HLP003 programs.