Helus Pharma Completes Enrollment in Phase 3 HLP003 Study Ahead of Schedule

Helus Pharma announced the completion of patient enrollment in its APPROACH Phase 3 pivotal study for HLP003, a treatment being developed for major depressive disorder (MDD). The study, which enrolled adults with moderate to severe MDD unresponsive to current antidepressants, reached its enrollment target ahead of the projected timeline.

The company expects to release topline data from the APPROACH study in the fourth quarter of 2026. Enrollment is ongoing for EMBRACE, the second pivotal Phase 3 study, and participants from both studies may transition to the EXTEND long-term safety and durability study.

HLP003 has previously received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA), highlighting its potential as a novel therapeutic for serious conditions. Data from earlier Phase 2 trials demonstrated durable efficacy in reducing depressive symptoms over time, generating significant anticipation for the drug's development.

"Completion of enrollment ahead of schedule demonstrates the focus and execution of our clinical team, investigators, and study partners," said Eric So, Interim Chief Executive Officer of Helus Pharma. He emphasized the high quality of the study population and the company's confidence in HLP003 as a potential new option for patients whose depression does not respond adequately to existing treatments.

Helus Pharma is targeting a New Drug Application (NDA) submission to the FDA in 2028. The company notes the growing market for advanced depression treatments, citing the performance of drugs like Johnson & Johnson's SPRAVATO as evidence of significant patient and provider demand for innovative psychiatric therapies.