Helus Pharma Enrolls Phase 3 Trial for Depression Drug HLP003

Helus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP) has announced the completion of 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 responded adequately to standard antidepressant therapy. The study enrolled 223 participants ahead of schedule, with topline results expected in the fourth quarter of 2026. HLP003 is an investigational deuterated psilocin analogue that has received FDA Breakthrough Therapy designation, positioning it as a potential intermittent treatment for major depressive disorder. The company continues enrollment in a second Phase 3 study, EMBRACE, and eligible participants may transition into the EXTEND long-term extension study to assess safety, durability of response, and potential redosing.

Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company focused on developing novel serotonergic agonists (NSAs) designed to activate serotonin pathways that promote neuroplasticity. The company’s PARADIGM clinical program aligns with recent FDA guidance for psychedelic drug development and is supported by a robust intellectual property portfolio comprising over 350 patent applications and more than 100 granted patents worldwide. Beyond HLP003, Helus Pharma is also developing HLP004, a proprietary NSA in Phase 2 for generalized anxiety disorder, and maintains an extensive research portfolio of investigational NSAs. The company operates in Canada, the United States, the United Kingdom, and Ireland.

This milestone marks a significant step toward addressing the large unmet need for effective treatments in major depressive disorder. With the APPROACH trial fully enrolled, Helus Pharma is advancing its mission to help minds heal through innovative therapies. For more details, the full press release is available at https://ibn.fm/NPu12. Investors can stay updated on the latest news regarding HELP at the company’s newsroom on InvestorBrandNetwork.