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

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies; the timing of and results from clinical trials and preclinical development activities; clinical and regulatory objectives and the timing thereof; expectations regarding the sufficiency of cash, cash equivalents, restricted cash, and investments to fund our planned operations through 2025; the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates; our ability to achieve additional milestones in our collaborations and proprietary programs; the progress and potential of our ongoing development programs; the timing of our public presentations and potential publication of future clinical data; the efficacy of our clinical trial designs; anticipated enrollment in our clinical trials and the timing thereof; expectations regarding our ongoing collaborations; and our ability to successfully develop and achieve milestones in our development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “intend,” and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and preclinical efforts may not yield additional product candidates; our discovery-stage and preclinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; the impact of pandemics, or other related health crises on our business, research and clinical development plans and timelines and results of operations, including the impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231103537555/en/