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. 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.
This milestone is significant because major depressive disorder affects millions worldwide, and many patients do not achieve adequate response to existing antidepressants. HLP003, as a novel serotonergic agonist, aims to provide durable improvements in mental health by promoting neuroplasticity. The completion of enrollment ahead of schedule suggests strong patient interest and efficient trial execution, potentially accelerating the timeline for bringing a new treatment option to market.
For more details, the full press release is available at https://ibn.fm/NPu12. Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company focused on developing proprietary novel serotonergic agonists. The company operates in Canada, the United States, the United Kingdom and Ireland. For company updates, visit www.helus.com.
