Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) announced that enrollment in its Phase 3 APPROACH clinical trial evaluating HLP003 for the adjunctive treatment of major depressive disorder has surpassed 86% and remains on track. The study is one of the company’s Phase 3 trials supporting development of HLP003, its lead proprietary novel serotonergic agonist, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration.
The APPROACH study is part of Helus Pharma’s broader Phase 3 PARADIGM program, which also includes the EMBRACE study and the EXTEND long-term extension study. The company said the enrollment milestone supports its goal of reporting topline data from APPROACH in the fourth quarter of 2026 as it advances HLP003 toward potential commercialization for patients with major depressive disorder.
Major depressive disorder affects millions worldwide, and current treatments often have limited efficacy or significant side effects. HLP003, a proprietary novel serotonergic agonist, is designed to activate serotonin pathways believed to promote neuroplasticity, offering a potential new approach to treating depression. The Breakthrough Therapy Designation from the FDA underscores the drug's potential to address a significant unmet medical need.
The enrollment milestone is a critical step in the clinical development process, bringing Helus Pharma closer to a potential New Drug Application submission. Success in the Phase 3 program could lead to a new treatment option for patients who have not responded adequately to existing therapies. The company's focus on novel serotonergic agonists represents a shift in the treatment landscape, aiming for durable improvements in mental health.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company committed to developing proprietary NSAs (novel serotonergic agonists). In addition to HLP003, the company is developing HLP004 for generalized anxiety disorder and has an extensive research portfolio of investigational NSAs. The company operates in Canada, the United States, the United Kingdom, and Ireland.
For more information, visit the company's newsroom at https://ibn.fm/HELP.
