Renalys Pharma launches to bring innovative medicines to patients in Japan and across Asia

Catalys Pacific, a transpacific life science investment firm, and SR One, a transatlantic life sciences investment firm, has announced the launch of Renalys Pharma, 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.

BT Slingsby, CEO, Renalys Pharma; Founder and Managing Director, Catalys Pacific: "The launch of Renalys Pharma exemplifies the power of global collaboration in biopharma. We will go beyond the lab to form cross-sectional partnerships that apply new technologies to enhance life for those living with renal disease. At Renalys Pharma, we are committed to bringing innovative new therapies to people living with rare kidney disease."

The company's all-encompassing approach seeks to provide end-to-end support so patients can live fuller, unencumbered lives. This innovative, patient-first mentality drives the work at Renalys Pharma.

Backed by two venture capital stalwarts - Catalys Pacific and SR One - Renalys Pharma unites the best of both firms' expertise to create an exciting new player dedicated to advancing renal disease treatments. The company has onboarded world-class talent in renal drug development and commercialization, composed mainly of former executives from Kyowa Kirin, who led the launch of multiple landmark renal therapies.

Catalys Pacific, with roots across the Pacific in Japan and the US, has a track record of building transpacific life sciences companies, including Mineralys Therapeutics and Pathalys Pharma in the US and Aculys Pharma in Japan. The integrated teams at Renalys Pharma, Catalys Pacific, and SR One reflect the global reach of biopharmaceutical collaboration. With end-to-end support from research to commercialization, Renalys Pharma has the pieces to rapidly advance new renal disease therapies. This worldwide cooperation exemplifies the borderless nature of life-changing science.

www.catalyspacific.com