Roche says kidney disease drug gets positive phase 3 test results

(AWP Alliance News) - Roche Holding AG on Wednesday reported positive developments from late-stage testing of its treatment for chronic kidney disease and said it plans to add the former head of a Japanese peer to its board.

The Basel, Switzerland-based pharmaceutical company said its ongoing Phase 3 clinical trial of sefaxersen, a subcutaneous drug designed to be self-injected by patients once a month, showed "best-in-class potential".

Sefaxersen is a candidate treatment for adults with primary immunoglobulin A nephropathy or Berger's disease, a chronic and progressive autoimmune kidney disease. In people with the condition, immune cells produce clumps of immunoglobulin A that block the kidney's filters, resulting in kidney damage that can require a transplant or dialysis.

Roche said Berger's disease leads to end-stage kidney disease in up to 50% of patients within 20 years of diagnosis, which typically occurs before the age of 40. The disease affects at least 25 adults per million worldwide each year.

Roche said patients treated with sefaxersen for 37 weeks achieved "statistically significant and clinically meaningful improvements" in reducing levels of immunoglobulin A in urine, which is an indicator of Berger's disease.

The company said no safety issues were identified. The study will continue to assess changes in kidney function over two years.

"For patients and families navigating immunoglobulin A nephropathy, the prospect of kidney failure, dialysis, or transplantation creates overwhelming uncertainty," said Bonnie Schneider, director and co-founder of the immunoglobulin A nephropathy foundation.

"As someone who has advocated for this community for over two decades, positive results from the study give us hope that emerging therapies could help preserve kidney function and transform the treatment landscape," Schneider said.

Separately, Roche said it would propose Christophe Weber for election to its board of directors at the annual general meeting on March 9, 2027.

Weber is the former chief executive officer of Tokyo-based Takeda Pharmaceutical Co Ltd.

Roche shares edged down 0.2% at CHF363.30 in Zurich on Wednesday afternoon.

By Camilla Borri, Alliance News reporter

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