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 demonstrates continued progress in the development of HLP003, a novel serotonergic agonist designed to activate serotonin pathways believed to promote neuroplasticity. Major depressive disorder affects millions worldwide, and many patients do not achieve adequate relief with existing treatments. HLP003, as an adjunctive therapy, could offer a new option for those who have not responded sufficiently to standard antidepressants.
The Breakthrough Therapy Designation from the FDA underscores the potential of HLP003 to address a serious condition and provides for more intensive FDA guidance and potential expedited review. The PARADIGM program includes multiple Phase 3 studies to generate robust efficacy and safety data required for regulatory submissions.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company focused on developing proprietary novel serotonergic agonists for mental health conditions. In addition to HLP003 for major depressive disorder, the company is developing HLP004 for generalized anxiety disorder, which is in Phase 2, and has an extensive research portfolio of investigational NSAs.
The company operates in Canada, the United States, the United Kingdom and Ireland. For Company updates and to learn more about Helus Pharma, 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 Phase 3 enrollment milestone is a key de-risking event for Helus Pharma. Meeting enrollment targets on schedule reduces timeline uncertainty and positions the company to deliver pivotal data in 2026. Positive results could support regulatory filings and potentially bring a new treatment option to patients with major depressive disorder, a condition with significant unmet need.
