Helus Pharma reports 86 percent enrollment in phase 3 depression trial

• Helus Pharma (NASDAQ:HELP) announced that its APPROACH Phase 3 trial of HLP003 for adjunctive treatment of major depressive disorder has surpassed 86% enrollment.
• The trial is progressing as planned, with topline data expected in Q4 2026.
• HLP003 holds FDA Breakthrough Therapy Designation and showed strong Phase 2 results, including a 23-point MADRS reduction at 12 months.

Helus Pharma (NASDAQ:HELP) reported that its APPROACH Phase 3 trial of HLP003 for adjunctive treatment of major depressive disorder has surpassed 86% enrollment and is progressing as planned.

HLP003 has received FDA Breakthrough Therapy Designation.

Topline Phase 3 data are expected in Q4 2026.

Previously reported Phase 2 data showed an approximately 23-point reduction in MADRS score at 12 months following two 16 mg doses administered three weeks apart.

Response and remission rates in the Phase 2 trial reached 75% at week 18 and 100%/71% at 12 months.

Helus Pharma is advancing HLP003 as a potential new adjunctive therapy for patients with major depressive disorder.

The company continues to focus on developing innovative treatments for mental health conditions with high unmet medical needs.