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 APPROACH study is part of the company’s broader Phase 3 PARADIGM program, which also includes the EMBRACE study and the EXTEND long-term extension study. HLP003, the company’s lead proprietary novel serotonergic agonist (NSA), has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration.
The enrollment milestone supports Helus Pharma’s goal of reporting topline data from APPROACH in the fourth quarter of 2026 as it advances HLP003 toward potential commercialization. Major depressive disorder affects millions worldwide, and there remains a significant unmet need for effective adjunctive treatments. HLP003 is designed to activate serotonin pathways believed to promote neuroplasticity, offering a novel mechanism that may provide 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. In addition to HLP003, the company 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.
The announcement of the enrollment milestone is a positive indicator for the progress of the PARADIGM program. If successful, HLP003 could become a new treatment option for patients with major depressive disorder who have not responded adequately to existing therapies. The Breakthrough Therapy Designation from the FDA underscores the potential of HLP003 to address a serious condition and may expedite its development and review process.
Investors and stakeholders will be watching closely for the topline data expected in late 2026. The results will be critical in determining the efficacy and safety of HLP003, and whether it can achieve regulatory approval. For more information, the full press release is available at https://ibn.fm/Qpikw.
