FILSPARI demonstrated a statistically significant, rapid, and sustained decline of proteinuria compared to the active control

Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced publication in The Lancet of the interim analysis of efficacy and safety data from the ongoing pivotal, Phase 3 PROTECT Study evaluating FILSPARI™ (sparsentan) in adults with IgA nephropathy (IgAN). The data are simultaneously being presented in a late-breaking trials session at the World Congress of Nephrology 2023, in Bangkok, Thailand.

“The data demonstrate the significant and clinically meaningful anti-proteinuric effect of sparsentan compared to irbesartan,” said Brad Rovin, M.D., Medical Director at Ohio State University Center for Clinical Research Management, Director of the Division for Nephrology, and steering committee member for the PROTECT Study. “The data also highlight a consistent treatment effect across patient populations, regardless of age, race, gender, clinical characteristics, and concomitant medications.”

The analysis published in The Lancet show that after 36 weeks of treatment, patients receiving FILSPARI achieved a mean reduction in proteinuria from baseline of 49.8%, compared to a mean reduction in proteinuria from baseline of 15.1% for irbesartan-treated patients (p<0.0001). During the double-blind treatment period, a significantly greater proportion of patients on FILSPARI achieved complete remission (urine protein excretion <0.3 g/day) and partial remission (urine protein excretion <1.0 g/day) of proteinuria compared to patients on irbesartan. Complete remission at any time over the course of the double-blind treatment period occurred in 20.8% of participants in the FILSPARI group and 7.9% of participants in the irbesartan group (p=0.0005). 70.3% of participants in the FILSPARI group achieved partial remission, compared to 44.1% of participants in the irbesartan group (p<0.0001).

“The interim data from the largest interventional trial testing a novel molecule versus an active comparator in IgA nephropathy conducted to date clearly demonstrate the more rapid and sustained reduction in proteinuria compared to irbesartan, including a significantly greater proportion of patients achieving complete and partial remission with FILSPARI,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. “These interim results also strengthen our confidence for a potential longer-term benefit on eGFR, which will be further examined at the completion of the 2-year double-blind period of the PROTECT trial later this year. We are thrilled to share this data with all those working to improve outcomes for people living with rare kidney disease.”

Results from the interim assessment in the PROTECT Study show that FILSPARI was well tolerated with a clearly defined safety profile that has been consistent across all clinical trials conducted to date with treatment-emergent adverse events (TEAEs) comparable to irbesartan. No cases of severe edema, heart failure, hepatotoxicity, or edema-related discontinuations were reported in the study as of the cutoff date. Body weight and blood pressure changes from baseline were not different between the FILSPARI and irbesartan groups.

The analysis published in The Lancet includes available efficacy data through the cutoff date of August 1, 2021, and available safety data through the cutoff date of February 1, 2022.