Renalys Pharma announces completion of patient enrollment in registrational Phase III clinical trial of sparsentan for IgA nephropathy in Japan

TOKYO, Jan. 30, 2025 /PRNewswire/ -- Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; "Renalys Pharma") announced today that it has completed patient enrollment 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 multicenter, 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 enrollment ahead of schedule," said BT Slingsby, MD, PhD, MPH, Chief Executive Officer and Executive Chairman of Renalys Pharma, Inc. "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, Inc. ("Travere"). Renalys Pharma has an exclusive license for development and commercialization of sparsentan in Japan, South Korea, Taiwan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam. In 2024, Travere received full FDA approval for sparsentan (U.S. 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.

Renalys Pharma is committed to advancing its business 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, first and foremost by delivering sparsentan as soon as possible.

*FILSPARI® (sparsentan) U.S. Indication:

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.

About IgA Nephropathy

The management of patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD) has become a social issue that places a heavy burden on the Japanese healthcare system. IgA nephropathy is widely known as one of the main causes of kidney failure and is considered to develop when abnormal IgA proteins are deposited in kidney tissue, inhibiting kidney function and causing inflammation. IgA nephropathy is a rare intractable disease (designated as an intractable disease 66) with many unresolved mechanisms of onset and severity. Currently, there is significant unmet need for approved treatment for IgA nephropathy in Japan.

About Renalys Pharma, Inc.

Renalys Pharma, a privately held late-stage clinical biopharmaceutical company based in Japan, is committed to the development of multiple innovative therapeutics targeting unmet needs in the management of renal disease for Japanese and Asian patients. Founded by Catalys Pacific and SR One in 2023, the company aims to address the growing problem of "drug loss" by catalyzing access to new treatments for kidney disease patients in Japan and other Asian regions.

Company Name: Renalys Pharma, Inc.
Address: 3-11, Nihonbashi-honcho 2-chome, Chuo-ku, Tokyo, Japan
Representative: BT Slingsby, MD, PhD, MPH
Established: April 2023
URL: https://renalys.com/

[Disclaimer]

Information concerning pharmaceutical products (compound under development) contained herein is not intended as advertising or as medical advice, but intended for disclosure of management information.

SOURCE Renalys Pharma, Inc.