Travere Misses Endpoint in Kidney Trial

 

• FILSPARI® (sparsentan) achieved a clinically meaningful difference vs. irbesartan in eGFR total slope (1.0 mL/min/1.73m2 per year) [p= 0.058] and eGFR chronic slope (1.1 mL/min/1.73m2 per year) [p=0.037]. Patients treated with FILSPARI over two years exhibited one of the slowest annual rates of kidney function decline seen in a clinical trial of IgAN patients (-2.7 to -2.9 mL/min/1.73m2 per year)
  

• eGFR chronic slope was statistically significant with respect to the confirmatory endpoint for the EU
  

• All topline efficacy endpoints favored FILSPARI
  

• FILSPARI was well-tolerated with a consistent safety profile comparable to irbesartan across all clinical trials conducted to date, supporting long-term use
  

• The Company will meet with regulators and expects to submit a supplemental New Drug Application (sNDA) in 1H 2024 for full approval in the U.S.

• Company to host conference call and webcast today at 8:30 a.m. ET

Travere Therapeutics will host a conference call and webcast today, Thursday, September 21, 2023, at 8:30 a.m. ET to discuss the Phase 3 PROTECT Study results. To participate in the conference call, dial +1 (888) 254-3590 (U.S.) or +1 (323) 994-2093 (International), confirmation code 5916006. The webcast can be accessed on the Investor page of Travere’s website at ir.travere.com/events-presentations. Following the live webcast, an archived version of the call will be available for 30 days on the Company’s website.

https://finance.yahoo.com/news/travere-therapeutics-announces-confirmatory-data-113000437.html