Alpine Immune Sciences to Present Povetacicept (ALPN-303) Phase 1 (RUBY-1) Study Data and Clinical Pharmacokinetic & Pharmacodynamic Modeling at Upcoming Scientific Conferences
ASCPT Annual Meeting
Poster Title: Early Clinical PK/PD Modeling and Simulation of Povetacicept, a Potent Dual BAFF/APRIL Antagonist, to Support Clinical Trials in Multiple Autoantibody-and/or B Cell-Related Diseases
Poster Number: PI-059
Poster Title: Phase 1 Study in Healthy Adults of the Safety, Tolerability, Pharmacokinetics, & Pharmacodynamics of Povetacicept (ALPN-303), a Dual BAFF/APRIL Antagonist for the Treatment of Autoimmune Glomerulonephritides
Poster Number: FRI-080
About Povetacicept (ALPN-303) and the RUBY-1 Phase 1 Study
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 the activation and survival of B cells, particularly antibody-secreting cells. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, povetacicept exhibits 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 B cell and/or autoantibody-related diseases, such as systemic lupus erythematosus, autoimmune glomerulonephritis, and autoimmune cytopenias.
RUBY-1 (NCT05034484) is a phase 1, randomized, placebo-controlled study in healthy adult volunteers designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of intravenously and subcutaneously administered povetacicept. Povetacicept was well tolerated at doses up to 960 mg, with dose-dependent pharmacokinetics and reductions in circulating immunoglobulins and antibody-secreting cells, supporting the use of a once every four-week dose regimen for subsequent studies.
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