Travere announces confirmatory data from Phase 3 PROTECT study of FILSPARI

Travere Therapeutics announced topline two-year confirmatory secondary endpoint results from the Company’s pivotal head-to-head Phase 3 PROTECT Study of FILSPARI in IgA nephropathy versus irbesartan. FILSPARI demonstrated long-term kidney function preservation and achieved a clinically meaningful difference in estimated glomerular filtration rate total and chronic slope versus irbesartan, narrowly missing statistical significance in eGFR total slope while achieving statistical significance in eGFR chronic slope for purposes of regulatory review in the EU. FILSPARI is currently available under accelerated approval in the U.S. The Company will engage with regulators and expects to submit a supplemental New Drug Application in 1H 2024 for full approval in the U.S. In the PROTECT Study, a total of 404 patients with persistent proteinuria despite active angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker treatment, were randomized 1:1 to receive once daily oral doses of either FILSPARI or irbesartan, the active control. eGFR total and chronic slope are the secondary confirmatory endpoints for the U.S. and the EU, respectively. All topline efficacy endpoints favored FILSPARI as compared to irbesartan. A preliminary review of the safety results through 110 weeks of treatment indicates FILSPARI was generally well-tolerated and the overall safety profile in the study has been consistent between treatment groups. The Company will complete a full evaluation of the data from the PROTECT Study and work with the study investigators on future presentations and publications of the results at an upcoming medical meeting and in a peer-reviewed publication.