Catalyst to access novel therapies for Asian patients with renal disease
Catalyst to access novel therapies for Asian patients with renal disease
Renalys Pharma is a private, late-stage clinical biopharmaceutical company in Japan committed to the development of innovative therapeutics that address unmet needs in the management of renal disease for Japanese and Asian patients.
The Problem
Renal Disease is a Growing Healthcare Priority in Japan
Management of patients with Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD) is increasingly placing a significant strain on the healthcare system and has become a substantial social concern.
Chronic Glomerulonephritis is the second leading cause of ESRD leading to dialysis in Japan. Within this disease category, IgA Nephropathy (IgAN) is the most prevalent primary glomerulonephritis worldwide. Often uncontrolled, progressive IgAN is a major cause of kidney failure.
IgAN occurs when IgA protein obstructs kidney function causing inflammation. Inflammation results in kidneys leaking blood and protein into the urine.
Current treatments for IgAN in Japan are inadequate and relies on steroids, RAAS blockade, and tonsillectomy with high concerns of adverse effects.
The Solution
Renalys Pharma was founded by Catalys Pacific and SR One to be a biopharmaceutical company in Japan, focused on the needs of Japanese and Asian patients with renal disease.
Renalys was launched with sparsentan, a first-in-class and best-in-class, oral Dual Endothelin Angiotensin Receptor Antagonist (DEARA), for the treatment of IgAN.
DEARA suppresses the progression of IgAN through reducing proteinuria by inhibiting two critical pathways, Endothelin-1 (ET-1) and Angiotensin II (Ang II).
Sparsentan is approved by FDA as the first non-immunosuppressive treatment for IgAN. It can be used in combination therapy with approved immunosuppressive agents in first-line therapy.
Beyond sparsentan, Renalys continues to identify high priority needs and potential solutions for patients with renal disease in Japan and Asia.
News
Sparsentan receives Orphan Drug Designation for primary IgA nephropathy in Japan
TOKYO, JAPAN, December 2, 2024 — Renalys Pharma, Inc., a late-stage clinical biopharmaceutical company announces that sparsentan, in-licensed from Travere Therapeutics, Inc. (“Travere”) and currently in phase III
Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy
FDA approves expanded indication making FILSPARI available to patients with IgA nephropathy (IgAN) at risk of progression; updated label includes data showing long-term durable benefit
Renalys Pharma announces first patient dosed in registrational Phase III clinical trial of sparsentan for IgA nephropathy in Japan
TOKYO, JAPAN, July 18, 2024 — Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; “Renalys Pharma”) announced today that the first person was dosed in its registrational