Healthcare
Viatris Announces Positive Top-Line Results from Phase 3 Study of VR-205 in Japanese Adults with Primary Immunoglobulin A Nephropathy
Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive top-line results from a Phase 3 clinical trial evaluating the efficacy and safety of VR-205 (targeted-release budesonide formulation) (Nefecon®) in Japanese adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of developing end-stage renal disease.
About this update from Viatris Inc.
VR-205 Met Primary Endpoint and Key Secondary Endpoints and Was Well Tolerated VR-205 Efficacy and Safety Profile in Japanese Patients Was Consistent with the Profile Observed in Global Studies Japanese New Drug Application Submission Targeted by End of 2026 PITTSBURGH and TOKYO, June 29, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive top-line results from a Phase 3 clinical trial evaluating the efficacy and safety of VR-205 (targeted-release budesonide formulation) (Nefecon®) in Japanese adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of developing end-stage renal disease. The Phase 3 clinical trial was a multicenter, interventional, open-label study designed to evaluate the efficacy and safety of 16 mg of VR-205 in Japanese adult patients with primary IgAN. Patients were treated for nine months, followed by a three-month follow-up period. The study achieved its primary endpoint, with VR-205 demonstrating a 33.75 percent reduction in geometric mean urine protein-to-creatinine ratio (UPCR) at 9 months compared to baseline [95% CI: -45.27 to -19.80; p < 0.001]. These results were statistically significant and clinically meaningful, and were consistent with those observed in the global Phase 3 program for the product. Key findings included: "We are pleased with these top-line results, which highlight VR-205 as a potentially meaningful, disease-modifying treatment option for patients with primary IgAN," said Viatris Chief R&D Officer Philippe Martin. "In Japan, where IgAN incidence is the highest globally, VR-205 could become the first IgAN-specific, targeted-release budesonide oral therapy. This progress reflects the continued execution of Viatris' strategy focused on building a differentiated and increasingly innovative portfolio in Japan, with an emphasis on delivering therapies that provide meaningful value and address significant unmet needs."