Helus Pharma reports Phase 2 topline signal detection results for HLP004 in adults with generalized anxiety disorder, including 6-week and 6-month outcomes

HLP004 Phase 2 signal detection results in adults with generalized anxiety disorder (GAD) show statistically significant and clinically meaningful improvements on top of standard of care (SoC) antidepressant therapy. In the study, 36 patients were randomized 2:1 to intramuscular HLP004 (20 mg or 2 mg) or placebo and received two doses three weeks apart, with follow-up through week 12 and observational follow-up up to one year. The company reports about a 10-point mean HAM-A reduction at six weeks for the 20 mg adjunct arm versus baseline on SoC (p<0.0001), with durable effects sustained through at least six months. Pooled results at six months are reported as 67% responders and 39% remitters. Helus Pharma also highlights practical dosing and tolerability, noting acute in-clinic effects lasting around 90 minutes and discharge readiness within about three hours, with generally well-tolerated adverse events and no drug-related serious adverse events or suicidality-related safety signals reported.