Helus Pharma Provides Update on APPROACH Phase 3 Trial Enrollment Progress

Executive Summary

• The APPROACH Phase 3 clinical trial for HLP003 (adjunctive treatment for major depressive disorder) has surpassed 86% enrollment and is progressing as planned.
• Previously reported Phase 2 data demonstrated robust long-term efficacy, including a ~23-point MADRS reduction at 12 months and 100% response/71% remission rates at the 12-month mark following a two-dose regimen.
• Helus Pharma remains on track for topline data readout in Q4 2026, building on HLP003's prior FDA Breakthrough Therapy Designation.

Key Details

• Trial & Drug: APPROACH Phase 3 clinical trial evaluating HLP003, a proprietary novel serotonergic agonist (NSA), for the adjunctive treatment of major depressive disorder (MDD).
• Enrollment Status: Trial has surpassed 86% enrollment and is progressing as planned.
• Phase 2 Long-Term Efficacy: Demonstrated a ~23-point reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score compared to baseline at 12 months.
• Dosing Regimen: Phase 2 efficacy was observed after two 16 mg doses of HLP003 administered three weeks apart.
• Phase 2 Response/Remission Metrics: Week 18 response and remission rates were 75%; by the 12-month mark, these improved to 100% response and 71% remission.
• Regulatory Status: HLP003 previously received FDA Breakthrough Therapy Designation.
• Data Readout Timeline: Company remains on track for topline data readout in the fourth quarter of 2026.
• Broader Clinical Program: APPROACH is part of the Phase 3 PARADIGM program, which also includes the EMBRACE study and the EXTEND long-term extension study, supporting advancement toward potential commercialization.

Notable Quotes

• Eric So, Interim Chief Executive Officer: “We are pleased with the continued progress of the APPROACH study as we surpass 86% enrollment. This milestone underscores the execution of our clinical program and brings us closer to the anticipated topline data readout in the fourth quarter of 2026. We remain focused on advancing HLP003 as a potential transformative treatment option for patients living with MDD.”