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. To view the full press release, visit https://ibn.fm/Qpikw.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical stage pharmaceutical company developing proprietary novel serotonergic agonists. These synthetic molecules are designed to activate serotonin pathways believed to promote neuroplasticity, addressing the large unmet need for people suffering from depression, anxiety, and other mental health conditions. With class-leading data, the company aims to improve the treatment landscape through durable improvements in mental health.
Beyond HLP003, Helus Pharma is developing HLP004, a proprietary NSA in Phase 2 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 updates and more information, visit www.helus.com.
The successful enrollment milestone underscores the potential of HLP003 to become a new treatment option for major depressive disorder, a condition affecting millions worldwide. The Breakthrough Therapy Designation from the FDA highlights the therapeutic promise of HLP003, and the completion of enrollment brings the company closer to demonstrating its efficacy and safety in a pivotal trial.
