Clinical Data Consistent with prior guidance, the Company is providing limited data from the interim analysis to maintain trial integrity in the ongoing study. In the PROTECT Study, a total of 404 patients with persistent proteinuria despite active ACE or ARB treatment, were randomized 1:1 to receive once daily oral doses of either sparsentan or irbesartan, the active control. The study protocol provided for an unblinded interim analysis to evaluate the primary efficacy endpoint – the change in proteinuria (urine protein-to-creatinine ratio) from baseline at Week 36 – approximately 36 weeks following randomization of the first 280 patients. After 36 weeks of treatment, patients receiving sparsentan achieved a mean reduction in proteinuria from baseline of 49.8 percent, compared to a mean reduction in proteinuria from baseline of 15.1 percent for irbesartan-treated patients (p<0.0001).


Secondary efficacy endpoints include the rate of change in estimated glomerular filtration rate (eGFR) following 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. The Company believes that preliminary eGFR data available at the time of the interim analysis are indicative of a potential clinically meaningful treatment effect after two years of treatment. Per study protocol, patients will continue in a blinded manner in the PROTECT Study to fully assess the treatment effect on eGFR slope over 110 weeks in the confirmatory endpoint analysis. Topline results from the confirmatory endpoint analysis are expected in the second half of 2023.