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

2024-07-18

TOKYO, July 18, 2024 /PRNewswire/ -- Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; "Renalys Pharma") announced today that the first person was dosed in its registrational Phase III clinical trial of sparsentan for the treatment of IgA nephropathy in Japan.

In April this year 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.

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 2023, Travere received FDA accelerated approval for sparsentan (U.S. brand name: FILSPARI®) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression*. In addition, Travere submitted a supplemental New Drug Application to FDA in March 2024 which was granted as Priority Review and a PDUFA target action date of September 5, 2024, to convert the existing U.S. accelerated approval to full approval based on 2-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 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 angiotensin II receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a UPCR ≥1.5 g/g.

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 a lack of treatment for IgA nephropathy and an unmet need for such treatment 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.