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. This milestone underscores progress toward addressing the large unmet need for patients with major depressive disorder who do not respond adequately to existing treatments.
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. With more than 86% of participants enrolled, the trial is progressing as planned, and the company expects to complete enrollment soon. The PARADIGM program is designed to evaluate the efficacy and safety of HLP003 in adults with major depressive disorder who have had an inadequate response to standard antidepressant therapy.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical stage pharmaceutical company focused on developing proprietary novel serotonergic agonists (NSAs) – synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The company’s lead candidate, HLP003, has already received Breakthrough Therapy Designation from the FDA, which is intended to expedite the development and review of drugs that show substantial improvement over existing therapies. In addition to HLP003, the company is developing HLP004 for generalized anxiety disorder, which is currently in Phase 2 trials, and has an extensive research portfolio of investigational NSAs.
The implications of this announcement are significant for the mental health treatment landscape. Major depressive disorder affects millions worldwide, and many patients do not achieve adequate relief with current antidepressants. HLP003, if approved, could offer a new mechanism of action that may provide durable improvements in depressive symptoms. The enrollment milestone also signals strong clinical trial execution and patient interest, which bodes well for the company’s ability to meet its development timelines. For investors, the progress of the APPROACH trial is a key catalyst, with topline data expected in late 2026. For more details, the full press release is available at https://ibn.fm/Qpikw. Additional information about Helus Pharma can be found at www.helus.com.
