Helus Pharma’s Phase 3 APPROACH trial of HLP003 for major depressive disorder has achieved 86% enrollment and remains on track for a Q4 2026 topline data readout, retaining its FDA Breakthrough Therapy status. Earlier Phase 2 showed a 23-point MADRS score reduction and up to 100% response at 12 months.
Helus Pharma’s APPROACH Phase 3 trial of HLP003 for adjunctive major depressive disorder has reached 86% patient enrollment, keeping the study on schedule for completion. This progress advances the program toward its planned topline data readout in the fourth quarter of 2026.
HLP003 retains FDA Breakthrough Therapy designation, granting the study intensive regulatory guidance and prioritized review. This status signals the agency’s engagement and enhances the potential for expedited development if key endpoints are met.
In earlier Phase 2 results, HLP003 demonstrated a mean 23-point reduction in Montgomery–Asberg Depression Rating Scale scores at 12 months, with response and remission rates of 100% and 71% respectively. These striking figures underscore the compound’s potential to deliver durable improvements over standard antidepressants.
APPROACH is part of Helus Pharma’s broader PARADIGM Phase 3 program, which includes EMBRACE and EXTEND studies to support a comprehensive safety and efficacy package. With hundreds of millions affected by major depressive disorder, a fast-acting adjunctive therapy could capture significant market share upon approval.
