Aurinia Pharma reports ‘positive’ results from Phase 1 study of aritinercept

Aurinia Pharmaceuticals (AUPH) announced positive results from a Phase 1 single-ascending-dose study of aritinercept, its dual inhibitor of B cell-activating factor and a proliferation-inducing ligand. 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 greater than or equal to3 adverse events, there were no treatment-related serious adverse events and there were no discontinuations due to treatment-related adverse events. Adverse events that occurred in more than one subject included injection site reactions, headache, upper respiratory tract infection and back pain. All injection site reactions were Grade 1. Single doses of aritinercept led to robust and long-lasting reductions in immunoglobulins. Specifically, mean reductions from baseline to Day 28 of up to 48%, 55% and 20% were observed for immunoglobulin A, immunoglobulin M and immunoglobulin G, 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.”