Catalys Pacific, a transpacific life science investment firm, and SR One, a transatlantic life sciences investment firm, have announced the launch of Renalys Pharma, Inc., a clinical-stage biopharmaceutical company focused on developing medicines and treatments for people with renal disease in Japan and certain other countries in Asia.

Renalys Pharma's efforts are centered on bringing sparsentan, an investigational dual-acting treatment developed by Travere Therapeutics, to IgA nephropathy patients in Japan and selected Asian countries.

Sparsentan is a dual endothelin and angiotensin receptor antagonist, providing a novel approach to treating IgA nephropathy, and is approved in the US under accelerated approval with the tradename FILSPARI.

Preclinical data shows sparsentan reduces proteinuria, protects podocytes, and prevents glomerulosclerosis and mesangial cell proliferation - major drivers of kidney disease progression. In 2023, Travere Therapeutics reported two-year results from the Phase 3 PROTECT Study, demonstrating long-term kidney function preservation.

Consultations with the Pharmaceuticals and Medical Devices Agency (PMDA) have been completed, with the regulatory agency agreeing to trial protocols in Japan. Renalys Pharma plans to initiate an open label registrational study of sparsentan in Japan in the second quarter of 2024, leveraging global pivotal studies already conducted, to support potential approval of sparsentan in Japan.

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. By providing the first non-immunosuppressive therapeutic specifically developed for IgA nephropathy, sparsentan could potentially protect kidney function for tens of thousands of patients.