SEATTLE--(BUSINESS WIRE)--Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced the Company presented new preclinical data on povetacicept in myasthenia gravis at the American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting (AANEM), November 1-3, 2023 in Phoenix, Arizona. In addition, the Company presented safety, tolerability, pharmacokinetic, and pharmacodynamic data from RUBY-1, a phase 1 study of povetacicept in healthy adult volunteers.
Key Takeaways:
- In a model of murine experimental autoimmune myasthenia gravis (EAMG), povetacicept improved disease activity, with clinical scores superior to treatment with either the FcRn inhibitor efgartigimod or an anti-CD20 depleting antibody. It also reduced anti-AChR IgG autoantibodies and serum Ig isotypes, including IgM and IgA, superior to both comparator treatments.
- In the RUBY-1 clinical trial, povetacicept was well tolerated in adult healthy volunteers as single intravenous or subcutaneous doses of up to 960 mg and exhibited dose-related pharmacokinetic and pharmacodynamic effects, including reductions in circulating Ig and antibody-secreting cells. The results support the use of an every four-week subcutaneous dosing regimen in future therapeutic studies.
“Relatively few approved drugs appear to be directed at the underlying disease pathogenesis of myasthenia gravis,” said Stanford Peng, MD PhD, President and Head of Research and Development at Alpine. “These data indicate that povetacicept might deliver efficacy superior to some therapeutics currently in clinical use for myasthenia gravis and other autoantibody-related neurological diseases. Given the encouraging clinical data we presented earlier this week with povetacicept in glomerulonephritis, particularly IgA nephropathy, we look forward to exploring other indications such as myasthenia gravis where povetacicept may be an active and convenient, yet potentially disease-modifying, treatment.”
American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting
Date/Time: Thursday, November 2, 2023, 6:00pm – 6:30pm PT and Friday, November 3, 2023 at 3:00pm – 3:30pm PT
Poster Title: Povetacicept (ALPN-303), a Potent Dual BAFF/APRIL Antagonist, for the Treatment of Myasthenia Gravis (MG) and Other Antibody-Related Diseases
Poster Board Number: 207
Location: Poster Hall, JW Marriott Phoenix Desert Ridge
Presenter: Marcia Friedman, M.D., Associate Medical Director, Alpine Immune Sciences
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 and B cell depletion. Povetacicept is in development for multiple autoimmune diseases, including IgA nephropathy and other autoimmune kidney diseases, systemic lupus erythematosus, and autoimmune cytopenias.
About Alpine Immune Sciences
Alpine Immune Sciences is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is seeking to create first- or best-in-class multifunctional immunotherapies via unique protein engineering technologies to improve patients’ lives. Alpine has entered into strategic collaborations with leading global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on Twitter and LinkedIn.
Forward-Looking Statements
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