Viatris Inc. (NASDAQ: VTRS), a US-based global healthcare company, announced on Monday 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 multicentre, 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.

According to Viatris, the study achieved its primary endpoint, with VR-205 demonstrating a 33.75% 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]. It claims that these results were statistically significant and clinically meaningful, and were consistent with those observed in the global Phase 3 program for the product.

Viatris is targeting submission of a New Drug Application in Japan by the end of 2026.