Renalys Pharma has announced last week that the first person was dosed in its registrational Phase III clinical trial of sparsentan for the treatment of immunoglobulin A (IgA) nephropathy in Japan.
Earlier this year, the company 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.
Sparsentan was developed by Travere Therapeutics, with Renalys Pharma holding an exclusive licence for development and commercialisation of sparsentan in Japan, South Korea, Taiwan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam. In 2023, Travere received US Food and Drug Administration (FDA) accelerated approval for sparsentan (US brand name: FILSPARI) to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression. In addition, Travere submitted a supplemental New Drug Application to the US FDA in March 2024, which was granted as Priority Review and a Prescription Drug User Fee Act (PDUFA) target action date of 5 September 2024, to convert the existing accelerated approval in the USA to full approval, based on two-year confirmatory results from the Phase III PROTECT study, the only head-to-head study in IgA nephropathy versus an active comparator. In the PROTECT study, FILSPARI demonstrated a significant reduction in proteinuria, preservation of kidney function, and a well-tolerated safety profile compared with active control irbesartan.
Renalys Pharma hopes that, by developing sparsentan as soon as possible, it will be able 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, as stated in a press release from the company.
