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, according to a press release. 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 major depressive disorder affects millions worldwide, and many patients do not respond adequately to existing treatments. HLP003, a proprietary novel serotonergic agonist, is designed to activate serotonin pathways believed to promote neuroplasticity, potentially offering a new option for those with unmet needs. The Breakthrough Therapy Designation from the FDA underscores the potential of HLP003 to address a serious condition where existing therapies fall short.
The implications of this announcement are far-reaching. If HLP003 proves successful in Phase 3, it could reshape the treatment landscape for depression, providing durable improvements in mental health. For the pharmaceutical industry, it validates the approach of targeting neuroplasticity through serotonergic agonists. For investors, the enrollment progress de-risks the development timeline, bringing the company closer to potential commercialization. Helus Pharma, the commercial operating name of Cybin Inc., is a clinical stage pharmaceutical company committed to developing proprietary NSAs – novel serotonergic agonists – for depression, anxiety, and other mental health conditions.
In addition to HLP003 for major depressive disorder, Helus Pharma is developing HLP004, a proprietary NSA for generalized anxiety disorder, currently in Phase 2. The company operates in Canada, the United States, the United Kingdom and Ireland. For more information, visit www.helus.com.
The full press release is available at https://ibn.fm/Qpikw. For the latest news and updates relating to HELP, visit the company’s newsroom at https://ibn.fm/HELP.
