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

Core Viewpoint - Helus Pharma announced positive results from a Phase 2a clinical trial of SPL026, a novel serotonergic agonist for treating major depressive disorder, demonstrating significant reductions in depressive symptoms compared to placebo [2][3][7]. Study Results - The Phase 2a trial met its primary endpoint, showing a mean difference of -7.35 in MADRS scores at two weeks for SPL026 compared to placebo, with a p-value of 0.023 [3][7]. - Significant reductions in depressive symptoms were observed as early as one week post-dosing, with effects lasting up to six months in some participants [3][4]. - Response rates for SPL026 were 35% at Week 2, compared to 12% for placebo, while remission rates were 29% for SPL026 versus 12% for placebo [4][7]. Treatment Safety and Efficacy - SPL026 was generally well tolerated, with no serious treatment-related adverse events reported [3][4]. - The study involved 34 participants with a mean age of 32.8 years, predominantly white, who had experienced depression for an average of 10.5 years [8]. Future Developments - Helus Pharma plans to advance HLP004, another proprietary NSA, for generalized anxiety disorder, with topline data expected in Q1 2026 [5][11]. - The findings from the SPL026 trial support the potential of short-acting serotonergic agonists in mental health treatments, reinforcing the company's strategy for developing novel serotonergic agonist molecules [5][7]. Company Overview - Helus Pharma is a clinical-stage pharmaceutical company focused on developing proprietary NSAs aimed at addressing mental health conditions such as depression and anxiety [10][11]. - The company operates in multiple regions, including Canada, the United States, the United Kingdom, and Ireland [12].