Renalys to Begin Phase III in IgA Nephropathy with $38M Funding

Japanese pharmaceutical firm Renalys Pharma has successfully secured JPY 6 billion ($38.4 million) in a series A funding round to initiate a registrational study for its IgA nephropathy treatment. This candidate drug, originally licensed from Travere Therapeutics earlier this year, holds significant potential in treating the chronic kidney disease.

Renalys Pharma has exclusive rights to develop and market sparsentan in Japan, where it is currently advancing through clinical trials. Additionally, the company has secured rights for several other markets in Asia, including South Korea, Taiwan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam. Travere Therapeutics retains rights to the drug outside these specified Asian regions.

Sparsentan is a dual endothelin angiotensin receptor antagonist that has already achieved accelerated approval status in the United States and conditional approval in the European Union, where it is marketed under the name Filspari. In the US, Travere has applied for full FDA approval as of March this year.

The upcoming Phase III study conducted by Renalys is set to commence in the second quarter of Japan's fiscal year, spanning from July to September. The results from this pivotal clinical trial are anticipated in the latter half of 2025.

The recent funding round was led by Catalys Pacific and SR One, both of which co-founded Renalys. Other notable investors involved in this round include JPS Growth Investment, Sumitomo Mitsui Trust Bank, Japan Co-Invest IV, and NVCC NO.9 Investment.

This financial injection will support Renalys in its efforts to bring sparsentan to market, addressing a significant unmet need for patients suffering from IgA nephropathy across various regions in Asia.