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 company is developing HLP003 and HLP004, another proprietary NSA in Phase 2 for generalized anxiety disorder.
This milestone is significant because it brings a potential new treatment option closer to patients suffering from major depressive disorder who do not respond adequately to existing therapies. The FDA Breakthrough Therapy designation underscores the potential of HLP003 to address a significant unmet medical need. If successful, HLP003 could offer a novel mechanism of action through serotonergic agonism that promotes neuroplasticity, potentially providing durable improvements in mental health.
Investors and industry observers will be watching for topline data in late 2026, which could impact the treatment landscape for depression. The company's intellectual property portfolio, with over 100 granted patents, provides a competitive moat. For more details, see the full press release at https://ibn.fm/NPu12.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical stage pharmaceutical company focused on developing novel serotonergic agonists for mental health conditions. With operations in Canada, the United States, the United Kingdom and Ireland, the company aims to address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions.
