Helus Pharma HLP003 Phase 3 Enrollment Hits 86%, On Track for Q4 2026 Data
GHRS•Helus Pharma’s APPROACH Phase 3 trial of HLP003 for adjunctive major depressive disorder has surpassed 86% enrollment, maintaining schedule for a Q4 2026 topline data readout. Previous Phase 2 results reported a 23-point average reduction on the MADRS scale at 12 months, with response rates reaching 100% and 71% remission.
1. Enrollment Milestone
Helus Pharma’s APPROACH Phase 3 trial of HLP003 for adjunctive major depressive disorder has surpassed 86% enrollment, putting the study on track for a scheduled topline data readout in Q4 2026 and demonstrating efficient recruitment across the US, Canada, UK and Ireland.
2. Phase 2 Efficacy Data
In prior Phase 2 studies, two 16 mg doses of HLP003 administered three weeks apart produced an average 23-point reduction on the Montgomery-Asberg Depression Rating Scale at 12 months, with response rates of 75% at week 18 improving to 100% and remission rates reaching 71% by month 12.
3. Breakthrough Therapy Designation
HLP003 has received FDA Breakthrough Therapy Designation based on early clinical evidence of substantial improvement over existing antidepressants, granting Helus Pharma more intensive regulatory guidance and potential accelerated review timelines for its Phase 3 program.
4. Market Opportunity
Major depressive disorder affects hundreds of millions worldwide and existing SSRIs and SNRIs often leave patients inadequately treated, creating a significant unmet need for rapid-acting, durable adjunctive therapies targeting neuroplasticity, positioning HLP003 as a potential transformative option.
