Ligand’s Partner Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI Demonstrating Long-Term Kidney Function Preservation in IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint versus Active Control

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.”

PROTECT Study Results

In the PROTECT Study, a total of 404 patients with persistent proteinuria despite active angiotensin-converting enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB) 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.

	FILSPARI (N=202)	Irbesartan (N=202)	Difference (FILSPARI - Irbesartan)
eGFR total slope, mL/min/1.73m2 per yeara	-2.9