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 Phase 3 PARADIGM program, which also includes the EMBRACE study and the EXTEND long-term extension study. The 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.
HLP003 is a proprietary novel serotonergic agonist (NSA) that has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. The designation is intended to expedite the development and review of drugs that show substantial improvement over existing therapies for serious conditions. Major depressive disorder affects millions globally, and many patients do not achieve adequate response with current treatments, highlighting the need for new options.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company focused on developing proprietary NSAs designed to activate serotonin pathways believed to promote neuroplasticity. The company’s pipeline also includes HLP004, an NSA in Phase 2 for generalized anxiety disorder, along with an extensive research portfolio of investigational NSAs. For more details on the APPROACH trial, the full press release is available at https://ibn.fm/Qpikw.
The company operates in Canada, the United States, the United Kingdom and Ireland. Helus Pharma aims to address the large unmet need for people suffering from depression, anxiety, and other mental health conditions through its class-leading data and innovative NSA platform. The completion of enrollment and subsequent data readout will be critical milestones for the company and for patients awaiting new therapeutic options.
