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. The completion of enrollment in the APPROACH trial marks a significant milestone for the company and for the field of psychedelic-assisted therapies, bringing a potential new treatment option closer to patients suffering from treatment-resistant depression.
Major depressive disorder affects millions worldwide, and many patients do not achieve adequate symptom relief with current antidepressants. HLP003, as an adjunctive treatment, could offer a novel mechanism of action by targeting serotonin pathways believed to promote neuroplasticity. The FDA Breakthrough Therapy designation underscores the potential of HLP003 to address this large unmet need.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical stage pharmaceutical company committed to developing proprietary novel serotonergic agonists (NSAs) designed to activate serotonin pathways. The company is also developing HLP004, a proprietary NSA in Phase 2 for generalized anxiety disorder, and has 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.
