ROCKVILLE, MD, USA & EDMONTON, Canada I September 05, 2024 I 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.
About AUR200
AUR200, a highly potent and specific immune modulator, is an IgG4 Fc-fusion protein with no appreciable effector function. AUR200 contains a unique, structurally engineered B-cell maturation antigen (BCMA) domain for enhanced binding to both BAFF and APRIL, two cytokines that play important roles in regulating B-cell survival and differentiation. Dual inhibition of BAFF and APRIL is a clinically validated mechanism that has demonstrated great therapeutic potential for a wide range of autoimmune diseases.
In animal data presented at the annual American College of Rheumatology Convergence 2022, AUR200 dosed therapeutically reduced several markers of disease activity and improved overall survival in a mouse model of lupus. AUR200 was also well-tolerated in both mice and cynomolgus monkeys, with no adverse effects. These findings highlight the potential value of AUR200 in the treatment of autoimmune diseases.i
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. The Company’s head office is in Edmonton, Alberta, with its U.S. commercial office in Rockville, Maryland. The Company focuses its development efforts globally.
SOURCE: Aurinia
Post Views: 2,093
ROCKVILLE, MD, USA & EDMONTON, Canada I September 05, 2024 I 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.
About AUR200
AUR200, a highly potent and specific immune modulator, is an IgG4 Fc-fusion protein with no appreciable effector function. AUR200 contains a unique, structurally engineered B-cell maturation antigen (BCMA) domain for enhanced binding to both BAFF and APRIL, two cytokines that play important roles in regulating B-cell survival and differentiation. Dual inhibition of BAFF and APRIL is a clinically validated mechanism that has demonstrated great therapeutic potential for a wide range of autoimmune diseases.
In animal data presented at the annual American College of Rheumatology Convergence 2022, AUR200 dosed therapeutically reduced several markers of disease activity and improved overall survival in a mouse model of lupus. AUR200 was also well-tolerated in both mice and cynomolgus monkeys, with no adverse effects. These findings highlight the potential value of AUR200 in the treatment of autoimmune diseases.i
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. The Company’s head office is in Edmonton, Alberta, with its U.S. commercial office in Rockville, Maryland. The Company focuses its development efforts globally.
SOURCE: Aurinia
Post Views: 2,093
