Nature Medicine Publishes Helus Pharma’s Randomized, Placebo-Controlled Phase 2a Trial of SPL026 in Major Depressive Disorder

Core Insights - Helus Pharma announced positive results from a Phase 2a clinical trial of SPL026 for major depressive disorder, showing significant reductions in depressive symptoms compared to placebo [2][3][7] Study Results - The study met its primary endpoint with a mean difference in MADRS score of -7.35 at two weeks, indicating a statistically significant reduction in depressive symptoms [3][7] - Participants treated with SPL026 showed reductions in symptoms as early as one week, with effects lasting up to six months in some cases [3][4] - Response rates for SPL026 were 35% compared to 12% for placebo, and remission rates were 29% versus 12% [4][7] Treatment Efficacy - A single 21.5 mg dose of SPL026 was well tolerated, with no serious adverse events reported [3][4] - The treatment effects were comparable to other longer-duration interventions, suggesting potential cost-effectiveness [4][5] Future Developments - Helus Pharma is advancing HLP004, another proprietary serotonergic agonist, with topline data expected from its Phase 2 study in generalized anxiety disorder in Q1 2026 [5][11] - Insights from the SPL026 trial are informing the development of HLP004, which aims to optimize pharmacology and scalability [5][11] Company Overview - Helus Pharma is focused on developing novel serotonergic agonists to address unmet needs in mental health, including depression and anxiety [10][11] - The company operates in multiple regions, including Canada, the United States, the United Kingdom, and Ireland [12]