Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announced that its partner Travere Therapeutics, Inc. (NASDAQ:TVTX) (“Travere”) today released topline, two-year confirmatory secondary endpoint results from its pivotal, head-to-head Phase 3 PROTECT Study of FILSPARI® (sparsentan) in IgA nephropathy (IgAN) versus irbesartan. FILSPARI demonstrated long-term kidney function preservation and achieved a clinically meaningful difference in estimated glomerular filtration rate (eGFR) 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. Travere will engage with regulators and expects to submit a supplemental New Drug Application (sNDA) in 1H 2024 for full approval in the U.S.
Under Ligand’s license agreement with Travere for FILSPARI, Ligand is entitled to receive net royalties of 9% on global net product sales of FILSPARI.
“We are encouraged by the results from the Phase 3 study reported by Travere today,” said Todd Davis, CEO of Ligand Pharmaceuticals. “The PROTECT study showed all topline efficacy endpoints favored FILSPARI, and patients treated with FILSPARI over two years exhibited one of the slowest annual rates of kidney function decline seen in clinical trials to-date. In addition, FILSPARI was well-tolerated with a consistent safety profile comparable to irbesartan across all clinical trials conducted to-date, supporting long-term use.”
