Aurinia Begins Dosing in AUR200 Trial

ROCKVILLE, MD, USA & EDMONTON, Canada I September 05, 2024 I Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) has announced the commencement of dosing for the first participant in a Phase 1a single ascending dose (SAD) study of AUR200. AUR200 is a novel therapeutic candidate for autoimmune diseases, designed to target both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand).

The Phase 1a SAD study aims to evaluate the safety, tolerability, pharmacokinetics, and biomarker changes associated with AUR200 in healthy volunteers. Results from this study are anticipated in the first half of 2025.

Dr. Greg Keenan, Chief Medical Officer of Aurinia, emphasized the significance of this milestone in the development of AUR200. He noted that AUR200 could potentially become a best-in-class treatment for autoimmune diseases, given its superior potency and higher binding affinity compared to other TACI-Fc molecules that target both BAFF and APRIL. He expressed optimism that the data from this early-stage study will distinguish AUR200 and guide further clinical development.

Aurinia's development plan for AUR200 includes targeting disease states with limited market competition, encompassing one major indication and one smaller, fast-to-market indication that qualifies for the FDA's orphan and rare disease criteria. The company plans to disclose specific indications and development strategies based on the progress and outcomes of early-stage clinical trials, as well as an ongoing evaluation of the competitive landscape. Aurinia intends to finance this development program using its available cash flow without affecting previously announced operating expense targets post-restructuring.

AUR200 is described as a highly potent and specific immune modulator, categorized as an IgG4 Fc-fusion protein without significant effector function. It features a uniquely engineered B-cell maturation antigen (BCMA) domain that enhances binding to BAFF and APRIL, cytokines crucial for B-cell survival and differentiation. The dual inhibition of BAFF and APRIL is a clinically validated mechanism offering significant therapeutic potential across various autoimmune diseases.

The therapeutic potential of AUR200 has been highlighted in animal studies presented at the American College of Rheumatology Convergence 2022. In these studies, AUR200 showed efficacy in reducing disease activity markers and improving overall survival in a lupus mouse model. Moreover, it was well-tolerated in both mice and cynomolgus monkeys, with no adverse effects reported. These findings underscore AUR200's potential value in treating autoimmune diseases.

Aurinia Pharmaceuticals is a biopharmaceutical company that focuses on delivering treatments for autoimmune diseases with significant unmet medical needs. In January 2021, Aurinia launched LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for adult patients with active lupus nephritis. The company is headquartered in Edmonton, Alberta, with a U.S. commercial office in Rockville, Maryland, and operates on a global scale.

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