Aurinia Pharma Reports Positive Results from Phase 1 Study of Aritinercept

Aurinia Pharma reported positive results from a Phase 1 single-ascending-dose study of aritinercept, a dual inhibitor of B cell-activating factor and a proliferation-inducing ligand. The study showed robust and long-lasting reductions in immunoglobulins after single doses of aritinercept. Aurinia plans to initiate clinical studies of aritinercept in at least two autoimmune diseases in the second half of this year.

Rockville, Md. & Edmonton, Alberta, June 30, 2025—(BUSINESS WIRE)—Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced positive results from a Phase 1 single-ascending-dose (SAD) study of aritinercept (AUR200), its dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL). The study, which involved 61 healthy subjects, evaluated aritinercept doses ranging from 5 mg to 300 mg, administered by subcutaneous injection. The trial demonstrated robust and long-lasting reductions in immunoglobulins (antibodies) after single doses of aritinercept.

The study showed mean reductions from baseline to Day 28 of up to 48%, 55%, and 20% for immunoglobulin A (IgA), immunoglobulin M (IgM), and immunoglobulin G (IgG), respectively. Aritinercept was well tolerated across all dose levels tested, with no treatment-related Grade ≥3 adverse events, no treatment-related serious adverse events (SAEs), and no discontinuations due to treatment-related adverse events. Injection site reactions, headache, upper respiratory tract infection, and back pain were the most common adverse events, with all injection site reactions being Grade 1.

Dr. Greg Keenan, Chief Medical Officer of Aurinia, commented, "Dual inhibition of BAFF and APRIL to modulate B cells, including plasma cells, holds great promise in the treatment of a wide range of autoimmune immune diseases where these cells produce disease-causing autoantibodies." Based on the positive results, Aurinia plans to initiate clinical studies of aritinercept in at least two autoimmune diseases in the second half of this year.

A webcast and conference call will be hosted today, June 30, at 8:30 a.m. ET. The link to the webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. A replay of the webcast will be available on Aurinia’s website.

References:
[1] https://finance.yahoo.com/news/aurinia-announces-positive-results-phase-100000207.html