Helus Pharma Provides Update on APPROACH Phase 3 Trial Enrollment Progress (opens original article in a new tab)

Helus Pharma reports that its Phase 3 APPROACH trial for HLP003 in major depressive disorder has exceeded 86% enrollment, with previous Phase 2 results showing significant efficacy, and anticipates topline data in Q4 2026.

• Helus Pharma's APPROACH Phase 3 trial for HLP003 in major depressive disorder has surpassed 86% enrollment.
• Phase 2 data showed HLP003 had a 23-point MADRS score reduction at 12 months with 100% response and 71% remission rates.
• The company expects topline data from the APPROACH trial in Q4 2026.