Benzinga | Sep 21, 2020 08:03AM EDT

Retrophin Announces Enrollment Of First 280 Patients In Pivotal Phase 3 PROTECT Study Of Sparsentan In IgA Nephropathy

SAN DIEGO, Sept. 21, 2020 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ:RTRX) today announced that the first 280 patients have been enrolled in the pivotal Phase 3 PROTECT Study evaluating the safety and efficacy of sparsentan in IgA nephropathy (IgAN). The PROTECT Study protocol provides for a pre-specified analysis to evaluate the proteinuria efficacy endpoint in at least 280 patients after 36 weeks of treatment. Successful achievement of the 36-week proteinuria endpoint is expected to support regulatory submissions for accelerated approval in the U.S. and Europe. Topline efficacy data from the 36-week proteinuria endpoint analysis are expected in the third quarter of 2021.



"With a lack of effective and durable treatment options available for people living with IgAN, many patients progress to end-stage renal disease requiring kidney transplant or dialysis," said Noah Rosenberg, M.D., chief medical officer of Retrophin. "We believe the continued progress of our PROTECT Study reflects the unwavering dedication of patients and investigators to support the development of treatment options that could have the potential to delay transplant or dialysis. As a result of achieving this important enrollment milestone in the PROTECT Study ahead of schedule, we are positioned to report top-line data next year from both the PROTECT Study and our pivotal DUPLEX Study in FSGS."

PROTECT is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled Phase 3 clinical trial expected to enroll approximately 380 patients with IgAN. Patients are randomized to receive either sparsentan or irbesartan, the active control. The proteinuria efficacy endpoint is the change in proteinuria (urine protein-to-creatinine ratio) at Week 36 compared to baseline. Secondary efficacy endpoints include the rate of change in eGFR from the initiation of randomized treatment over 58-week and 110-week periods, as well as the rate of change in eGFR over 52-week and 104-week periods following the first six weeks of randomized treatment in approximately 380 patients.