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 one of the company’s Phase 3 trials supporting development of HLP003, its lead proprietary novel serotonergic agonist, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration.
The APPROACH study is part of Helus Pharma’s broader Phase 3 PARADIGM program, which also includes the EMBRACE study and the EXTEND long-term extension study. The company said the enrollment milestone supports its 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. This milestone is significant because it brings the company closer to addressing a large unmet need in mental health treatment.
HLP003 is a proprietary novel serotonergic agonist designed to activate serotonin pathways believed to promote neuroplasticity. If successful, it could offer a new option for patients who do not respond adequately to existing antidepressants. The FDA’s Breakthrough Therapy Designation underscores the potential of HLP003 to provide a meaningful improvement over current therapies. The PARADIGM program’s progress is closely watched by investors and the medical community, as major depressive disorder affects millions worldwide and many patients fail to achieve remission with standard treatments.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical stage pharmaceutical company focused on developing proprietary NSAs – novel serotonergic agonists. Beyond HLP003, the company has HLP004 in Phase 2 for generalized anxiety disorder and 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.
