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 part of the company’s broader PARADIGM program, which also includes the EMBRACE study and the EXTEND long-term extension study. HLP003, a proprietary novel serotonergic agonist, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, underscoring its potential to address a significant unmet need in mental health.
The enrollment milestone supports Helus Pharma’s goal of reporting topline data from the APPROACH study in the fourth quarter of 2026, advancing HLP003 toward potential commercialization. Major depressive disorder affects millions worldwide, and current treatments often have limited efficacy or delayed onset. HLP003 is designed to activate serotonin pathways believed to promote neuroplasticity, potentially offering durable improvements in symptoms.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company focused on developing proprietary novel serotonergic agonists (NSAs). Beyond HLP003, the company is developing HLP004 for generalized anxiety disorder, currently in Phase 2, and has an extensive research portfolio of investigational NSAs. The company operates in Canada, the United States, the United Kingdom, and Ireland.
The APPROACH trial’s progress is a critical step for Helus Pharma as it seeks to bring a new treatment option to patients with major depressive disorder. With Breakthrough Therapy Designation, the drug may benefit from expedited development and review. The company’s focus on neuroplasticity-driven therapies could differentiate HLP003 from existing antidepressants, which often require weeks to take effect.
For more details, the full press release is available at https://ibn.fm/Qpikw. Investors can find the latest news and updates at https://ibn.fm/HELP.
