Helus Pharma HLP004 Phase 2 Delivers 10.4-Point HAM-A Drop, 67% Responders
Helus Pharma’s HLP004 Phase 2 study in generalized anxiety disorder achieved a 10.4-point mean HAM-A reduction at six weeks (p<0.0001), with 67% responders and 39% remitters at six months. The company appointed former Pfizer CMO Freda Lewis-Hall to its board and held US$195.1 million in cash to fund its pipeline.
1. Phase 2 HLP004 Efficacy in GAD
Helus Pharma randomized 36 adults with moderate-to-severe generalized anxiety disorder to receive two intramuscular doses of HLP004 (20 mg or 2 mg) three weeks apart. Patients on 20 mg adjunctive to standard care achieved a mean 10.4-point HAM-A reduction at six weeks (p<0.0001), with 67% responders and 39% remitters at six months.
2. Board Appointment of Freda Lewis-Hall
Helus appointed Dr. Freda Lewis-Hall to its board and as Scientific Advisory Committee chair. Lewis-Hall brings over a decade as Pfizer’s Executive Vice President and Chief Medical Officer and led the spinout of SpringWorks Therapeutics, later acquired for $3.4 billion.
3. Cash Reserves and Pipeline Development
As of December 31, 2025, Helus held US$195.1 million in cash to advance its multi-asset pipeline. Its lead oral asset, HLP003, holds Breakthrough Therapy Designation and showed 100% response and 71% remission at 12 months in Phase 2; pivotal Phase 3 topline data are expected in Q4 2026.