Renalys Pharma has completed patient enrolment 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 multicentre, 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 enrolment ahead of schedule,” said BT Slingsby, chief executive officer and executive chairman of Renalys Pharma. “Through our continued collaboration and efforts, we are seeking to deliver this innovative treatment of sparsentan to patients as quickly as possible.”
Sparsentan was developed by Travere Therapeutics. 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 US Food and Drug Administration (FDA) approval for sparsentan, under the 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.
Filspari is an endothelin and angiotensin II receptor antagonist indicated to slow kidney function decline in adults with primary IgA nephropathy who are at risk of disease progression.