Renalys Pharma Commences Patient Dosing in registrational Phase Trial

Renalys Pharma, Inc. reported the dosing of the initial participant in its phase III clinical trial of sparsentan for IgA nephropathy treatment in Japan. Renalys submitted an Investigational New Drug (IND) Application for sparsentan to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in April of this year.

The phase III clinical study for registration is a single arm, open-label, multicenter study for Japanese individuals with IgA nephropathy. It aims to validate the safety and effectiveness of sparsentan in around 30 Japanese patients. Anticipated findings from the UP/C endpoint in the research will be available in the latter part of 2025 to back up a request for approval from PMDA.

Travere Therapeutics, Inc created Sparsentan. Renalys Pharma holds a unique license to develop and sell Sparsentan in various Asian countries. In 2023, the FDA granted accelerated approval to Travere for sparsentan (known as Filspari in the US) to decrease proteinuria in adults with primary IgAN who are at risk of quick disease advancement.

Furthermore, Travere filed an additional New Drug Application with the FDA in March 2024, which was designated as Priority Review. The PDUFA target action date is set for September 5, 2024, to transition the current US accelerated approval to full approval using 2-year confirmatory data from the phase III PROTECT study, the sole head-to-head comparison in IgA nephropathy against an active comparator. In the PROTECT research, Filspari showed a notable decrease in proteinuria, maintenance of kidney function, and a well-received safety profile when compared to the active control irbesartan.