Japanese biotech Renalys Pharma has raised $37.8 million (¥6 billion) in a Series A round to work on an approval in Japan for the drug Filspari in a rare kidney disease.
Renalys took over the rights to Filspari through a licensing agreement with Travere Therapeutics, which scored an approval with the FDA for the treatment of IgA nephropathy in February 2023. In the licensing deal, Travere got an undisclosed upfront payment and could receive up to $120 million in milestones, plus tiered royalties on Asia sales.
This financing round will fund Renalys’ Phase 3 trial for the drug in Japan. The open-label trial started in the second quarter of this year, and data from the urine protein ratio endpoint are expected in the second half of 2025. According to Renalys, IgA nephropathy is prevalent in Asia.
The financing round was led by Catalys Pacific and SR One, and backed by additional investors JPS Growth Investment, Sumitomo Mitsui Trust Bank, Japan Co-Invest IV and NVCC NO.9 Investment.
“Our investment in Renalys reflects our confidence in their ability to develop much-needed new medicines for patients in Japan and across Asia,” Rajeev Dadoo, managing partner of SR One, wrote in a statement.
In the first quarter of 2024, Filspari brought in $19.8 million and also scored a priority review from the FDA to convert the drug’s accelerated approval to a full approval, with a PDUFA date of Sept. 5, 2024.
Travere is also investigating the drug in combination with sodium glucose cotransporter-2 inhibitors (SGLT2i) and expects data from that as well as from the ongoing SPARTAN trial evaluating Filspari as a first-line therapy in newly diagnosed IgA nephropathy this year.