The unmet medical need relates to the management of a renal disease. Specifically, the buildup of immunoglobulin A (IgA) in the kidneys characterises a rare kidney disease known as IgA nephropathy (IgAN). The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), protein in the urine (proteinuria) and a progressive loss of kidney function. Current treatments in Japan are inadequate and rely on steroids, renin angiotensin aldosterone system (RAAS) blockade, and tonsillectomy with high concerns of adverse effects.

Sparsentan is a dual endothelin and angiotensin receptor antagonist, providing a novel approach to treating IgAN. Sparsentan is approved in the US under accelerated approval with the tradename FILSPARI®. In 2023, Travere reported two-year results from the Phase 3 PROTECT Study, demonstrating long-term kidney function preservation. By providing the first non-immunosuppressive therapeutic specifically developed for IgAN, sparsentan could potentially protect kidney function for tens of thousands of patients in Japan and other countries in Asia.

Travere was looking for a dedicated partner to develop and commercialize sparsentan in Japan and other countries in Asia. Travere discussed the partnering opportunity with a number of potential partners, but saw the greatest potential in working with Catalys Pacific and helping to create a new company focused on renal disease – Renalys. Renalys is led by distinguished renal experts with a strong track record of launching kidney disease treatments. It was clear to us that Renalys has the expertise and resources to rapidly advance sparsentan to enable people living with IgAN in Japan and other countries in Asia to have access to this innovative therapy as quickly as possible. Through this transpacific collaboration, we are confident that sparsentan has the potential to address a severe unmet medical need and ultimately change lives for people living with IgAN in Japan and other countries in Asia.

Yes, transpacific strategic collaborations like this one have the potential to greatly benefit other biopharmaceutical companies in the US and Europe, in particular those seeking to enter the Japan and Asia markets. Newly created expert-led venture-backed companies are able to bring innovative medicines into new markets and rapidly develop these assets by leveraging their knowledge and connections. We look forward to seeing Renalys, and other newly created companies using this model, succeed in improving access to innovative medicines.