Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule
Helus Pharma completed enrollment in its Phase 3 APPROACH study of HLP003 for Major Depressive Disorder, enrolling 223 participants ahead of schedule. The study remains on track for a topline data readout in Q4 2026, positioning the company for a potential New Drug Application in 2028. HLP003 previously received FDA Breakthrough Therapy Designation.
Key figures
- Phase2 response rate
- 100%
- Participants enrolled
- 223
- Phase2 remission rate
- 71%
- Phase2 madrs reduction
- ~23-point
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