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 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 Helus Pharma's lead proprietary novel serotonergic agonist (NSA), designed to activate serotonin pathways believed to promote neuroplasticity. The drug has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, underscoring its potential to address the large unmet need for patients with major depressive disorder. The Phase 3 program is a critical step toward bringing a new treatment option to patients who have not responded adequately to existing therapies.
The announcement comes as Helus Pharma continues to build momentum in its clinical pipeline. Beyond HLP003, the company is developing HLP004, another proprietary NSA currently in Phase 2 for generalized anxiety disorder. Helus Pharma also maintains an extensive research portfolio of investigational NSAs aimed at improving mental health outcomes. The company operates in Canada, the United States, the United Kingdom, and Ireland, and is the commercial operating name of Cybin Inc., founded in 2019.
The APPROACH trial's enrollment progress is a positive indicator for the development timeline. With over 86% of participants enrolled, the study remains on schedule, and the company anticipates data readout in late 2026. If successful, HLP003 could offer a new mechanism of action for treating major depressive disorder, a condition affecting millions worldwide. The Breakthrough Therapy Designation from the FDA provides an expedited development pathway, potentially accelerating the drug's path to market.
Investors and stakeholders can find the latest news and updates regarding HELP in the company's newsroom at https://ibn.fm/HELP. For more details on the company and its pipeline, visit www.helus.com. Helus Pharma's focus on proprietary NSAs represents a novel approach to mental health treatment, leveraging synthetic molecules designed to promote neuroplasticity and durable improvements in mood and anxiety disorders.
