Helus Pharma plans Phase 2 HLP004 anxiety trial for first quarter of 2027
CYBN•Helus Pharma expects to begin a Phase 2 trial of HLP004 for generalized anxiety disorder in the first quarter of 2027, evaluating the treatment against placebo in approximately 144 adults. It expects HLP003 Phase 3 results in the fourth quarter of 2026 and plans to submit an application for the treatment in 2028.
1. Trial plans and timeline
Helus Pharma expects a Phase 2 trial of HLP004 as a standalone treatment for generalized anxiety disorder to begin in the first quarter of 2027. The study will assess efficacy and safety against placebo in approximately 144 adults. The company expects topline results from its HLP003 APPROACH Phase 3 trial for adjunctive treatment of major depressive disorder in the fourth quarter of 2026. HLP003 has FDA Breakthrough Therapy Designation, and Helus Pharma expects to submit a New Drug Application in 2028.
