Aurinia starts Phase 4 study combining Lupkynis with other lupus drugs

Aurinia Pharmaceuticals (NASDAQ: AUPH) announced the initiation of PRESERVE, a Phase 4 multicenter study examining the combination of its drug Lupkynis with belimumab, obinutuzumab, or anifrolumab in patients with lupus nephritis, according to a company press release.

The study plans to enroll approximately 150 patients across roughly 50 sites in the United States. The primary endpoint is the proportion of patients achieving complete renal response at six months.

Lupkynis is FDA-approved as an oral therapy for lupus nephritis. Belimumab is approved for both systemic lupus erythematosus and lupus nephritis, obinutuzumab is approved for lupus nephritis, and anifrolumab is approved for systemic lupus erythematosus.

Anca Askanase, MD, MPH, Chair of the Department of Medicine and Chief of the Division of Rheumatology at Hospital for Special Surgery and co-lead investigator of PRESERVE, noted that even with recently approved agents, the majority of patients do not achieve complete renal response by six months, and many do not achieve it by 12 months.

Co-lead investigator Arvind Madan, MD, of Central Florida Kidney Specialists, said the combination targets distinct biological pathways. Lupkynis stabilizes podocytes and inhibits T cell activation, while belimumab and obinutuzumab inhibit B cell activation, and anifrolumab blocks type 1 interferon signaling.

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