Single Doses of Aritinercept Led to Robust and Long-Lasting Reductions in Immunoglobulins
Pharmacodynamic Effects Supportive of Once-Monthly Dosing
Plan to Initiate Clinical Studies in at Least Two Autoimmune Diseases in the Second Half of This Year
Aurinia to Host Conference Call Today, June 30, at 8:30 a.m. ET
ROCKVILLE, MD, USA & EDMONTON, Canada I June 30, 2025 I 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 investigated aritinercept doses of 5 mg, 25 mg, 75 mg, 150 mg, 225 mg and 300 mg and placebo, administered by subcutaneous injection, in 61 healthy subjects.
Aritinercept was well tolerated at all dose levels tested. There were no treatment-related Grade ≥3 adverse events, there were no treatment‑related serious adverse events (SAEs) and there were no discontinuations due to treatment-related adverse events. Adverse events that occurred in more than one subject included injection site reactions (24% aritinercept, 13% placebo), headache (11% aritinercept, 7% placebo), upper respiratory tract infection (7% aritinercept, 0% placebo) and back pain (4% aritinercept, 0% placebo). All injection site reactions were Grade 1.
Single doses of aritinercept led to robust and long-lasting reductions in immunoglobulins (antibodies). Specifically, mean reductions from baseline to Day 28 of up to 48%, 55% and 20% were observed for immunoglobulin A (IgA), immunoglobulin M (IgM) and immunoglobulin G (IgG), respectively.
“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,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia. “Based on today’s positive results, which indicate robust and long‑lasting pharmacodynamic effects supportive of once-monthly dosing, we plan to initiate clinical studies of aritinercept in at least two autoimmune diseases in the second half of this year.”
Webcast & Conference Call Details
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. Click here for participant International Toll-Free access numbers. A replay of the webcast will be available on Aurinia’s website.
About Aurinia
Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA‑approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing aritinercept (AUR200), a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases.
SOURCE: Aurinia
Post Views: 926
Single Doses of Aritinercept Led to Robust and Long-Lasting Reductions in Immunoglobulins
Pharmacodynamic Effects Supportive of Once-Monthly Dosing
Plan to Initiate Clinical Studies in at Least Two Autoimmune Diseases in the Second Half of This Year
Aurinia to Host Conference Call Today, June 30, at 8:30 a.m. ET
ROCKVILLE, MD, USA & EDMONTON, Canada I June 30, 2025 I 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 investigated aritinercept doses of 5 mg, 25 mg, 75 mg, 150 mg, 225 mg and 300 mg and placebo, administered by subcutaneous injection, in 61 healthy subjects.
Aritinercept was well tolerated at all dose levels tested. There were no treatment-related Grade ≥3 adverse events, there were no treatment‑related serious adverse events (SAEs) and there were no discontinuations due to treatment-related adverse events. Adverse events that occurred in more than one subject included injection site reactions (24% aritinercept, 13% placebo), headache (11% aritinercept, 7% placebo), upper respiratory tract infection (7% aritinercept, 0% placebo) and back pain (4% aritinercept, 0% placebo). All injection site reactions were Grade 1.
Single doses of aritinercept led to robust and long-lasting reductions in immunoglobulins (antibodies). Specifically, mean reductions from baseline to Day 28 of up to 48%, 55% and 20% were observed for immunoglobulin A (IgA), immunoglobulin M (IgM) and immunoglobulin G (IgG), respectively.
“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,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia. “Based on today’s positive results, which indicate robust and long‑lasting pharmacodynamic effects supportive of once-monthly dosing, we plan to initiate clinical studies of aritinercept in at least two autoimmune diseases in the second half of this year.”
Webcast & Conference Call Details
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. Click here for participant International Toll-Free access numbers. A replay of the webcast will be available on Aurinia’s website.
About Aurinia
Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA‑approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing aritinercept (AUR200), a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases.
SOURCE: Aurinia
Post Views: 926
