Retrophin announces publishing of Phase 2 DUET study results
Retrophin announced that the Journal of the American Society of Nephrology, or JASN, has published the positive results from the Phase 2 DUET Study of sparsentan for the treatment of focal segmental glomerulosclerosis, or FSGS, a rare kidney disorder that often leads to end-stage renal disease, or ESRD. As previously reported, these results demonstrated that the sparsentan treatment group experienced a greater than two-fold reduction of proteinuria compared to the irbesartan treatment group after an eight-week, double-blind treatment period. The publication is being highlighted as part of the Best of ASN Journals session at ASN Kidney Week and will also appear in the November print issue of JASN. An analysis of the secondary endpoint of the study showed that during the eight-week, double-blind treatment period, a significantly greater proportion of patients receiving sparsentan achieved the FSGS partial remission of proteinuria endpoint, or FPRE, defined as UP/C: less than or equal to 1.5 g/g and greater than 40% reduction of proteinuria from baseline, compared to irbesartan-treated patients. In addition, data from patients who were followed out to 48 weeks in the open-label sparsentan treatment period of DUET demonstrated a steady rise in the percentage of patients who achieved FPRE, reaching approximately 60% in patients originally randomized to either sparsentan or irbesartan.