Helus Pharma Phase 3 Trial Surpasses 86% Enrollment, Data Readout Q4 2026
HELP•Helus Pharma reports its APPROACH Phase 3 trial for HLP003 has achieved over 86% enrollment and remains on schedule for a topline data readout in Q4 2026. HLP003, granted FDA Breakthrough Therapy status, previously showed a 23-point MADRS reduction with 100% response at 12 months in Phase 2.
1. Phase 3 Enrollment Progress
Helus Pharma’s APPROACH Phase 3 trial of HLP003 for adjunctive major depressive disorder has surpassed 86% patient enrollment and is proceeding as planned, supporting the target for a topline data readout in the fourth quarter of 2026.
2. Impact of Breakthrough Therapy Designation
HLP003 has received FDA Breakthrough Therapy status, ensuring enhanced regulatory guidance and potential expedited review, reflecting early clinical promise against existing treatment options for major depressive disorder.
3. Strong Phase 2 Efficacy Signals
In the Phase 2 study, HLP003 produced an approximately 23-point reduction in MADRS scores at 12 months following two 16 mg doses, with response rates improving to 100% and remission reaching 71%, underscoring its potential durability.
