Clinical TrialJun 24, 2026, 06:01 AM
Helus Pharma HLP003 Phase 3 MDD Trial Surpasses 86% Enrollment
AI Summary
Helus Pharma announced that enrollment in its APPROACH Phase 3 clinical trial for HLP003, an adjunctive treatment for major depressive disorder (MDD), has surpassed 86% and is progressing as planned. The company anticipates a topline data readout in Q4 2026. HLP003, which has received FDA Breakthrough Therapy Designation, previously demonstrated strong long-term efficacy in Phase 2 data, including a ~23-point reduction in MADRS score and improved response and remission rates of 100% and 71% respectively at 12 months.
Key Highlights
- APPROACH Phase 3 trial for HLP003 in MDD has surpassed 86% enrollment.
- HLP003 is Helus Pharma's lead proprietary novel serotonergic agonist (NSA).
- Phase 2 HLP003 data showed ~23-point MADRS reduction at 12 months.
- Phase 2 HLP003 response and remission rates improved to 100% and 71% at 12 months.
- HLP003 previously received Breakthrough Therapy Designation from the FDA.
- Company remains on track for topline data readout in Q4 2026.
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