Renalys

Renalys Pharma is a late-stage clinical biopharmaceutical company established in April 2023, with a specific focus on addressing unmet needs in renal disease management for patients in Japan and other Asian countries. The company was co-founded by venture capital firms Catalys Pacific and SR One, with the strategic goal of mitigating "drug loss" by accelerating access to new treatments for kidney disease in the region. The co-founders are BT Slingsby, who also serves as CEO, and Takeshi Takahashi. BT Slingsby's role as the Founder and Managing Director of Catalys Pacific highlights the deep integration between the investment firm and Renalys's operational strategy, aiming to build transformative biotechnology companies. The leadership team includes world-class talent, notably former executives from Kyowa Kirin with a proven history of launching significant renal therapies in Japan.

The company's business model centers on in-licensing promising therapeutics and navigating them through clinical development and regulatory approval in its target markets. Renalys operates in the biopharmaceutical sector, specifically targeting the nephrology market in Japan and 13 other Asian territories, including South Korea, Taiwan, and parts of Southeast Asia. Its establishment was a direct response to the growing healthcare burden of Chronic Kidney Disease (CKD) and End-Stage Renal Disease (ESRD) in Japan. In July 2024, Renalys secured ¥6.0 billion (approximately $38.2 million) in a Series A financing round co-led by its founding investors, Catalys Pacific and SR One, to fund its clinical operations.

The cornerstone of Renalys's current pipeline is sparsentan, an oral, dual-acting antagonist of endothelin and angiotensin receptors (DEARA). This therapeutic was in-licensed from Travere Therapeutics. Sparsentan is being developed for the treatment of IgA nephropathy (IgAN), a major cause of kidney failure that is particularly prevalent in Asia. The drug offers a non-immunosuppressive treatment approach by inhibiting two critical pathways, Endothelin-1 (ET-1) and Angiotensin II (Ang II), which are involved in the progression of the disease. Sparsentan is already approved in the U.S. under the brand name FILSPARI® for reducing proteinuria in adults with primary IgAN. Following the submission of an Investigational New Drug (IND) application in April 2024, Renalys initiated a Phase III clinical trial for sparsentan in Japan, with initial results anticipated in the latter half of 2025.

Keywords: Renalys Pharma, renal disease, nephrology, biopharmaceutical, Japan, Asia, BT Slingsby, sparsentan, IgA nephropathy, Catalys Pacific, SR One, clinical trials, kidney disease, drug development, Travere Therapeutics, late-stage clinical, venture capital, therapeutics, FILSPARI, Endothelin Angiotensin Receptor Antagonist