SOL-116 - BEYOND

Rheumatoid arthritis (RA) remains a devastating autoimmune disease, affecting 5 million Europeans. Despite advances with biologics and JAK inhibitors, up to 40% of patients fail to respond or lose efficacy, while current treatments rely on broad immunosuppression, exposing patients to severe infections and long-term complications. There is an urgent unmet need for safer, more effective therapies. The SOL-116-BEYOND project directly addresses this gap by advancing SOL-116, a first-in-class humanized monoclonal antibody developed by Lipum, targeting bile salt-stimulated lipase (BSSL)—a previously overlooked driver of inflammation. Unlike existing biologics, SOL-116 interrupts inflammation while sparing normal immune function. Building on strong preclinical data and Phase I results confirming safety, target engagement, and favorable pharmacokinetics, BEYOND will further develop SOL-116 through a phase 2 clinical trial, to demonstrate efficacy in the target population, enabling out licensing and further commercialisation. BEYOND is structured in three pillars: (1) a multicenter phase 2a clinical trial to establish efficacy and safety, (2) biomarker discovery and mechanistic insights to validate BSSL as a therapeutic target and enable patient stratification, and (3) health economics and patient-centered research to demonstrate societal and market value. The lean, highly complementary consortium, comprising Lipum (developer of SOL-116), Age labs (Immunology/bioanalytics), Centre for Human Drug Research (clinical trials advisor) and MERAccess (health-economics), ensures scientific excellence, operational feasibility, and translational impact. BEYOND will pioneer safer, non-immunosuppressive RA treatment, strengthen Europe’s leadership in precision immunology, and position the consortium at the forefront of biotech innovation. SOL-116 has the potential to reduce disability, improve quality of life, and achieve multi-billion-euro savings for European healthcare systems.