Viatris has reported positive topline data from a Phase III trial assessing VR-205, a targeted-release budesonide, also known as Nefecon, in Japanese adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for end-stage renal disease.
The multicentre, interventional, open-label trial enrolled 39 participants who received 16mg daily of VR-205 over nine months, followed by a three-month follow-up including a dose taper.
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The study reached its primary endpoint. VR-205 reduced urine protein-to-creatinine ratio (UPCR) by 33.75% at nine months compared to baseline. The data was consistent with outcomes from the global Phase III programme for this product.
VR-205 also showed significant improvement in estimated glomerular filtration rate, and reductions in serum creatinine and urine albumin-to-creatinine ratio at nine months.
The overall therapeutic benefit included improvement in microhematuria and persistent proteinuria reduction. No study participants advanced to dialysis, kidney transplant or severe renal impairment by the end of the trial.
The treatment was generally well tolerated over nine months, aligning with the known safety profile of targeted-release budesonide in non-Japanese populations.
Viatris chief research and development officer Philippe Martin said: “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. 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.”
Viatris plans to submit a new drug application in Japan by the end of 2026. VR-205 is licensed from Calliditas Therapeutics and is already marketed as Tarpeyo in the US and as Kinpeygo in Europe for IgAN.
In June 2025, Viatris’ presbyopia drug MR-141 (phentolamine ophthalmic solution 0.75%) met the primary endpoint and all secondary endpoints in a second Phase III trial.
