Retrophin Doses First Patient in Pivotal Phase 3 PROTECT Study of Sparsentan for the Treatment of IgA Nephropathy

Retrophin (NASDAQ:RTRX) today announced that the first patient has been dosed in the PROTECT Study, a global, pivotal Phase 3 clinical trial evaluating the long-term nephroprotective potential of sparsentan for the treatment of IgA nephropathy (IgAN), a rare kidney disorder that often leads to end-stage renal disease (ESRD).

As quoted in the press release:

The PROTECT Study is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled Phase 3 clinical trial evaluating the safety and efficacy of sparsentan for the treatment of IgAN. Approximately 280 patients with IgAN, aged 18 years or older, are expected to be randomized to receive either sparsentan (initial dose of 200 mg daily for two weeks, titrating up to a target dose of 400 mg daily) or an active control, irbesartan (initial dose of 150 mg daily for two weeks, titrating up to a target dose of 300 mg daily).

The primary efficacy endpoint in the study is the change in proteinuria (urine protein-to-creatinine ratio) from baseline after 36 weeks of treatment. Retrophin expects that successful achievement of this endpoint will support submission of a New Drug Application (NDA) under the Subpart H accelerated approval pathway in the United States, as well as an application for Conditional Marketing Authorization (CMA) in Europe. Secondary efficacy endpoints include change in estimated glomerular filtration rate (eGFR) from baseline to four weeks post-cessation of randomized treatment, as well as the rate of change in eGFR over 52-week and 104-week periods following the first six weeks of randomized treatment. Retrophin expects enrollment in the PROTECT Study to complete in the first half of 2021, and top-line data from the 36-week primary endpoint efficacy analysis to become available in the first half of 2022.

Click here to read the full press release.