Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) has reported 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 included 61 healthy subjects and investigated aritinercept doses of 5 mg, 25 mg, 75 mg, 150 mg, 225 mg, and 300 mg, as well as a placebo, administered by subcutaneous injection.
The key findings from the study indicate that aritinercept was well tolerated at all dose levels tested, with no treatment-related grade ≥3 adverse events or serious adverse events. Moreover, there were no discontinuations due to treatment-related adverse events. The most common adverse events included injection site reactions, headache, upper respiratory tract infection, and back pain, with injection site reactions being graded as 1.
Importantly, 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.
Dr. Greg Keenan, Chief Medical Officer of Aurinia, expressed optimism about the potential of aritinercept in treating autoimmune diseases, citing the robust and long-lasting pharmacodynamic effects supportive of once-monthly dosing. As a result of the positive results, the company plans to initiate clinical studies of aritinercept in at least two autoimmune diseases in the second half of this year.
Aurinia Pharmaceuticals Inc. is a biopharmaceutical company focused on addressing the needs of individuals living with autoimmune diseases with high unmet medical needs. In January 2021, the company launched Lupkynis® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Additionally, the company is developing aritinercept (AUR200) for the potential treatment of autoimmune diseases. Today the company's shares have moved 0.12% to a price of $8.64. If you want to know more, read the company's complete 8-K report here.
