Aurinia Pharmaceuticals has dosed the first subject in a Phase Ia single ascending dose (SAD) clinical trial of AUR200, as a potential treatment for autoimmune diseases.
The trial is designed to evaluate the safety, tolerability, pharmacokinetics, and biomarker changes of AUR200 in healthy volunteers.
Results from the study are expected in the first half of next year, the company said.
AUR200 is an IgG4 Fc-fusion protein claimed to have minimal effector function.
It targets both B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), crucial cytokines in B-cell survival, and differentiation regulation.
The B-cell maturation antigen (BCMA) domain of AUR200 allows for enhanced binding to BAFF and APRIL.
Dual inhibition of these cytokines is said to be a clinically validated mechanism with significant therapeutic potential for various autoimmune diseases.
The company plans to develop AUR200 for disease states with limited current market options, including a larger indication and a faster-to-market smaller indication that aligns with the FDA criteria for rare and orphan diseases.
Specific indications and development plans will be communicated by the company, contingent on the progress and outcomes of early-stage clinical trials and an ongoing assessment of the competitive landscape for the relevant indications.
Aurinia Pharmaceuticals intends to fund this development programme with its available cash flow, which is not expected to affect the company's post-restructuring operating expense targets.
In animal studies, therapeutic dosing of AUR200 demonstrated a reduction in several markers of disease activity and improved overall survival in a mouse model of lupus.
Aurinia Pharmaceuticals chief medical officer Dr Greg Keenan said: “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.”
In November 2021, the company reported positive interim results from the AURORA 2 continuation study of Lupkynis (voclosporin) to treat lupus nephritis.
