Clinical TrialJul 21, 2026, 07:51 AM
Helus Pharma completes enrollment in APPROACH Phase 3 MDD study
AI Summary
Helus Pharma announced the completion of enrollment in its APPROACH Phase 3 pivotal study for HLP003, a novel serotonergic agonist for Major Depressive Disorder (MDD). This milestone advances the company toward the expected release of topline data in the fourth quarter of 2026. HLP003 previously received FDA Breakthrough Therapy Designation, and Phase 2 data demonstrated durable efficacy with significant reductions in MADRS scores and high remission rates. Enrollment is also continuing in EMBRACE, the second pivotal study in the PARADIGM Program.
Key Highlights
- Helus Pharma completed enrollment in APPROACH Phase 3 pivotal study for HLP003 in MDD.
- APPROACH study enrolled 223 participants with moderate to severe MDD.
- Topline data readout for APPROACH is on track for Q4 2026.
- HLP003 previously received FDA Breakthrough Therapy Designation.
- Phase 2 data showed a mean ~23-point reduction in MADRS score 12 months after two doses.
- Phase 2 data demonstrated 100% response and 71% remission rates (or 100% using peer-study benchmarks).
- Enrollment continues in EMBRACE, the second pivotal Phase 3 study.
- Participants from APPROACH and EMBRACE can roll over into the EXTEND long-term study.
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