Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) announced it has completed enrollment in its pivotal Phase 3 APPROACH trial evaluating HLP003 as an adjunctive treatment for adults with moderate to severe major depressive disorder who have not achieved an adequate response to antidepressant therapy. The study enrolled 223 participants ahead of schedule, with topline results from the primary and key secondary endpoints expected in the fourth quarter of 2026.
HLP003, an investigational deuterated psilocin analogue, has received FDA Breakthrough Therapy designation and is being evaluated as a potential intermittent treatment for major depressive disorder. The company said enrollment continues in the second Phase 3 EMBRACE study, while eligible participants may transition into the EXTEND long-term extension study to evaluate safety, durability of response and potential redosing.
Helus Pharma said the broader PARADIGM clinical program was designed to align with recent FDA guidance for psychedelic drug development and is supported by an intellectual property portfolio that includes more than 350 patent applications and more than 100 granted patents worldwide. To view the full press release, visit https://ibn.fm/NPu12.
Helus Pharma, the commercial operating name of Cybin Inc., founded in 2019, is a clinical stage pharmaceutical company committed to helping minds heal by developing proprietary NSAs – novel serotonergic agonists: synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The company’s proprietary NSAs are intended to address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions.
With class leading data, Helus Pharma aims to improve the treatment landscape through the introduction of NSAs that aim to provide durable improvements in mental health. Helus Pharma is currently developing HLP003, a proprietary NSA, in Phase 3 clinical development for the adjunctive treatment of major depressive disorder that has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration and HLP004, also a proprietary NSA in Phase 2 for generalized anxiety disorder. Additionally, Helus Pharma 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 or follow the team on X, LinkedIn, YouTube and Instagram. Helus Pharma is a trademark of Cybin Corp.
This development matters because it represents a significant step toward a potential new treatment for major depressive disorder, a condition affecting millions worldwide. The FDA Breakthrough Therapy designation underscores the potential of HLP003 to address an unmet medical need. If successful, this could transform the treatment landscape for patients who do not respond to existing antidepressants, offering a novel approach with durable improvements.
