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Aurinia Announces Positive Results from Phase 1 Study of Aritinercept (AUR200)
Single Doses of Aritinercept Led to Robust and Long-Lasting Reductions in Immunoglobulins Pharmacodynamic Effects Supportive of Once-Monthly Dosing Plan to
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\nSingle Doses of Aritinercept Led to Robust and Long-Lasting Reductions in Immunoglobulins\n\n\nPharmacodynamic Effects Supportive of Once-Monthly Dosing\n\n\nPlan to Initiate Clinical Studies in at Least Two Autoimmune Diseases in the Second Half of This Year\n\n\nAurinia to Host Conference Call Today, June 30, at 8:30 a.m. ET\n\n\n ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--\nAurinia 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.\n\n\nAritinercept 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.\n\n\nSingle 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.\n\n\n“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.”\n\n\nWebcast & Conference Call Details\n\n\nA webcast and conference call will be hosted today, June 30, at 8:30 a.m. ET. The link to the webcast is a...