Viatris Reports Significant Results from VR-205 Clinical Trial
Viatris announced top-line results from a Phase 3 clinical trial evaluating the efficacy and safety of VR-205 in Japanese adult patients with primary immunoglobulin A nephropathy 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% reduction in geometric mean urine protein-to-creatinine ratio at nine months compared to baseline. These results were statistically significant and clinically meaningful, and were consistent with those observed in the global Phase 3 program for the product. In addition to a statistically significant and clinically meaningful reduction in UPCR at 6 and 12 months, VR-205 demonstrated a significant improvement in estimated glomerular filtration rate and reductions in serum creatinine and urine albumin-to-creatinine ratio at 9 months compared to baseline. The overall therapeutic benefit of VR-205 was further supported by improvements in microhematuria and a sustained proteinuria reduction. No study participants progressed to dialysis, kidney transplant or severe renal impairment by the end of the study. VR-205 was generally well tolerated over the nine-month treatment period, with a safety profile consistent with the known safety profile of targeted-release budesonide in non-Japanese patients. Viatris is targeting submission of a new drug application in Japan by the end of 2026. In 2022, Calliditas Therapeutics and Viatris Pharmaceuticals Japan Inc., a subsidiary of Viatris entered into an exclusive license agreement to obtain marketing authorization and to commercialize VR-205 for the treatment of primary IgAN in Japan. It is currently a specialty drug approved and marketed as Tarpeyo in the U.S. and as Kinpeygo in Europe.
