Viatris announced positive top-line results from a Phase 3 clinical trial of VR-205, a targeted-release budesonide, in Japanese adults with primary immunoglobulin A nephropathy. The study met its primary endpoint, showing a statistically significant 33.75% reduction in urine protein-to-creatinine ratio after nine months of treatment, along with improvements in kidney function and sustained proteinuria reduction. The treatment was well tolerated, with no participants progressing to dialysis, kidney transplant, or severe renal impairment. Viatris plans to submit a New Drug Application in Japan by the end of 2026, aiming to make VR-205 the first IgAN-specific targeted-release budesonide oral therapy in the country.
Viatris IncPositive Phase 3 results for VR-205 in IgAN patients, meeting primary endpoint with significant proteinuria reduction.