Lupus Nephritis Research
Aurinia begins PRESERVE study, combining LUPKYNIS with other therapies for lupus nephritis patients.
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Aurinia Pharmaceuticals (NASDAQ: AUPH) has launched PRESERVE, a Phase 4 clinical study testing LUPKYNIS in combination with three other drugs — belimumab, obinutuzumab, or anifrolumab — in patients with lupus nephritis, according to Financial Post. Lupus nephritis is a serious kidney disease caused by lupus, an autoimmune condition where the body attacks its own tissues.
The study's main goal is to measure how many patients reach a complete renal response — meaning their kidneys are working normally again — within six months, Montreal Gazette reported. Aurinia says the disease still has significant unmet need, meaning current treatments do not work well enough for many patients.
What PRESERVE Is Testing and Why It Matters
PRESERVE is a multicenter Phase 4 study, meaning it runs across multiple hospitals and clinics. It tests LUPKYNIS — Aurinia's flagship drug — alongside one of three other approved medicines: belimumab, obinutuzumab, or anifrolumab, Ontario Farmer reported. Each of these drugs works differently to calm the immune system. Combining them could attack lupus nephritis from more than one angle at once.
The primary endpoint is complete renal response at the six-month mark, according to Cold Lake Sun. That means doctors will check whether patients' kidney function, protein levels in urine, and other key markers return to normal. Hitting that target at six months would be a strong signal that the combination therapy is working.
LUPKYNIS Already Approved, Now Being Combined With Biologics
LUPKYNIS (voclosporin) was the first oral drug specifically approved to treat lupus nephritis in adults. It works by blocking a protein called calcineurin, which plays a key role in the immune attack on the kidneys. Aurinia is now asking whether pairing it with biologic drugs — medicines made from living cells that target specific parts of the immune system — can push response rates even higher.
Belimumab, obinutuzumab, and anifrolumab each target different immune pathways. Belimumab blocks a protein called BAFF that helps B cells survive. Obinutuzumab destroys B cells directly. Anifrolumab blocks interferon, a key driver of lupus flares. Together with LUPKYNIS, these combinations could address multiple immune triggers at once, Mitchell Advocate reported.
Aurinia Also Developing Aritinercept for Autoimmune Diseases
Beyond PRESERVE, Aurinia is working on a second drug called aritinercept. It is a dual inhibitor, meaning it blocks two targets at the same time: BAFF and a protein called APRIL, according to Paris Star Online. Both proteins help immune cells survive and multiply. Blocking both could be more powerful than blocking just one.
Aritinercept is being developed for autoimmune diseases more broadly, not just lupus nephritis. This gives Aurinia a potential second pipeline asset beyond LUPKYNIS. The company has not yet announced Phase 3 trial dates for aritinercept, Fort Saskatchewan Record reported.
Lupus Nephritis Remains a Hard Disease to Treat
Lupus nephritis affects up to 50% of people with systemic lupus erythematosus (SLE). It is one of the most serious complications of lupus and can lead to permanent kidney damage or kidney failure if left untreated. Despite several approved therapies, many patients still do not achieve full kidney remission, Clinton News Record reported.
That gap is exactly what Aurinia is targeting with PRESERVE. By testing three different combination regimens in one study, the company hopes to find at least one pairing that meaningfully improves complete response rates above what LUPKYNIS alone can achieve. Results at the six-month primary endpoint will be a key milestone to watch.
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