Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company) announced today that the first participant has been dosed in a Phase 1a single ascending dose (SAD) study of AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand).
The SAD study will assess the safety, tolerability, pharmacokinetics, and changes in biomarkers for AUR200 in healthy volunteers, with data expected in the first half of 2025.
“The start of the single ascending dose study is an important milestone for developing AUR200, which has the potential to serve as a best-in-class treatment in autoimmune diseases with high unmet need. We believe AUR200 is a more potent compound with a higher binding affinity compared to the two other TACI-Fc molecules designed to bind both BAFF and APRIL that were tested in our preclinical research. We expect the data from this early-stage study to provide key points of differentiation that will inform further clinical development efforts,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia.
The Company intends to develop AUR200 in disease states where there are currently few market entrants, including one larger indication and one fast-to-market smaller indication that meets the FDA criteria for orphan and rare diseases. The Company will communicate specific indications and development plans pending progress and outcomes of early-stage clinical trials and based on ongoing assessment of the competitive landscape in relevant indications. The Company anticipates funding this development program with available cash flow, which is not anticipated to impact previously announced post-restructuring operating expense targets.