Renalys Pharma, Inc. has announced that it has completed patient enrollment for its registrational Phase III clinical trial of sparsentan for the treatment of IgA nephropathy in Japan.

In April 2024 Renalys submitted an Investigational New Drug (IND) Application for sparsentan to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. The registrational Phase III study is a multicenter, open-label, single arm study in Japanese patients with IgA nephropathy, and is planned to confirm the efficacy and safety of sparsentan in approximately 30 Japanese patients. Results from the urine protein/creatinine ratio (UP/C) endpoint in the study are expected in the second half of 2025 to support a submission for approval to PMDA.

"We are deeply grateful to the participating medical institutions for their tremendous efforts, enabling Renalys to complete patient enrollment ahead of schedule," said BT Slingsby, MD, PhD, MPH, Chief Executive Officer and Executive Chairman of Renalys Pharma, Inc. 

"Through our continued collaboration and efforts, we are seeking to deliver this innovative treatment of sparsentan to patients as quickly as possible," added Slingsby.

Sparsentan was developed by Travere Therapeutics, Inc. Renalys Pharma has an exclusive license for development and commercialisation of sparsentan in Japan, South Korea, Taiwan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam. 

In 2024, Travere received full FDA approval for sparsentan (US brand name: FILSPARI®) to slow kidney function decline in adults with primary IgA nephropathy who are at risk of disease progression. Full approval is based on positive long-term confirmatory results from the PROTECT Study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan. In the PROTECT Study, the only head-to-head study in IgA nephropathy versus an active comparator, FILSPARI® demonstrated a significant reduction in proteinuria, preservation of kidney function and a well-tolerated safety profile compared with active control irbesartan.

Renalys Pharma is committed to advancing its business to contribute to improving the lives of patients in Japan and Asia through the development of innovative therapies that can improve the management of kidney disease, first and foremost by delivering sparsentan as soon as possible.