Renalys Pharma begins Phase III trial of sparsentan for IgA nephropathy in Japan

Renalys Pharma, Inc., headquartered in Chuo-ku, Tokyo, has commenced the dosing of the first participant in a Phase III clinical trial of sparsentan for treating IgA nephropathy in Japan. This follows the company's submission of an Investigational New Drug (IND) application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in April 2024.

The Phase III trial is designed as a multicenter, open-label, single-arm study involving approximately 30 Japanese patients. The primary objective is to verify the efficacy and safety of sparsentan for IgA nephropathy. Key results focusing on the urine protein/creatinine ratio (UP/C) endpoint are anticipated in the latter half of 2025. These findings will be crucial for a subsequent submission for approval to the PMDA.

Sparsentan, initially developed by Travere Therapeutics, Inc., is licensed exclusively to Renalys Pharma for development and commercialization across various regions, including Japan, South Korea, Taiwan, and several Southeast Asian countries. In 2023, Travere secured FDA accelerated approval for sparsentan (marketed as FILSPARI® in the U.S.) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of rapid disease progression. Additionally, Travere has filed a supplemental New Drug Application with the FDA, aiming for full approval based on two-year confirmatory results from the Phase III PROTECT Study. This study is significant as it is the only one conducted with a head-to-head comparison in IgA nephropathy against an active comparator.

Renalys Pharma is devoted to enhancing the lives of patients in Japan and Asia by pioneering innovative treatments for kidney diseases. The company’s primary focus is on delivering sparsentan promptly to the market, leveraging its potential to significantly improve the management of IgA nephropathy.

IgA nephropathy, a leading cause of kidney failure, occurs when abnormal IgA proteins deposit in kidney tissue, leading to inhibited kidney function and inflammation. It is considered a rare and challenging disease with many unresolved mechanisms and currently lacks effective treatment options. This condition places a substantial burden on Japan's healthcare system due to the management demands of chronic kidney disease (CKD) and end-stage renal disease (ESRD).

Renalys Pharma, established in April 2023, is a private late-stage clinical biopharmaceutical company. It was founded by Catalys Pacific and SR One with the mission to address critical unmet needs in renal disease management for patients in Japan and Asia. The company is based in Tokyo and aims to bridge the gap in drug availability, providing new treatment options for kidney disease patients in the region.