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 Phase 3 PARADIGM program, which also includes the EMBRACE study and the EXTEND long-term extension study. 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 for patients with major depressive disorder.
HLP003 is Helus Pharma's lead proprietary novel serotonergic agonist (NSA), which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. The drug is designed to activate serotonin pathways believed to promote neuroplasticity, addressing the large unmet need for people suffering from depression and other mental health conditions. The APPROACH trial is one of the company's Phase 3 studies supporting the development of HLP003, which aims to 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, another proprietary NSA in Phase 2 for generalized anxiety disorder. Helus Pharma also 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 www.helus.com.
The latest news and updates relating to HELP are available in the company's newsroom at https://ibn.fm/HELP. The full press release can be viewed at https://ibn.fm/Qpikw.
