Alpine Immune Sciences Announces Initiation of Dosing in 240 mg IgA Nephropathy Cohort of Povetacicept Clinical Study (RUBY-3)

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced the successful initiation of the second IgA nephropathy (IgAN) dose cohort in RUBY-3, a phase 1b/2a study in autoimmune glomerulonephritis.

• Safety Monitoring Committee (SMC) review has determined that repeat dosing of povetacicept in the first IgAN dose cohort (80 mg subcutaneously once every 4 weeks) has been safe and well-tolerated to date, with no serious or severe adverse events, no events of hypogammaglobulinemia (IgG < 3g/L), and no instances of hypersensitivity or administration-related reactions.
• Dose escalation has been endorsed, and enrollment of the second IgAN dose cohort (240 mg subcutaneously every 4 weeks) has been initiated.

“We are encouraged by this first in-disease experience with the lowest dose level of povetacicept in this study, confirming its initial safety and pharmacodynamic activity during multiple dose administration,” noted Stanford Peng, President and Head of Research and Development at Alpine. “We look forward to providing more detailed clinical updates later this year in appropriate scientific forums.”

About Povetacicept (ALPN-303)

Povetacicept (ALPN-303) is a dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, which play key roles in pathogenesis of multiple autoimmune diseases via their roles in the activation, differentiation and/or survival of B cells, particularly antibody-secreting cells, as well as T cells and innate immune cells. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, povetacicept has exhibited greater potency in preclinical studies versus wild-type TACI-based comparators, as well as other inhibitors of BAFF and/or APRIL alone. Povetacicept is in development for multiple autoimmune diseases, such as systemic lupus erythematosus, autoimmune glomerulonephritis, and autoimmune cytopenias.

About RUBY-3

RUBY-3 (NCT05732402) is a multiple ascending dose, multi-cohort, open label, phase 1b/2a study of povetacicept in IgA nephropathy, lupus nephritis, and primary membranous nephropathy, where povetacicept is being administered subcutaneously for up to 48 weeks. Key endpoints include proteinuria, eGFR, renal response, and disease-related autoantibodies.