Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced that the Company presented new preclinical data from a study of povetacicept in a murine experimental autoimmune myasthenia gravis (EAMG) model during the 148^th Annual American Neurological Association (ANA) Meeting in Philadelphia, PA. In addition, the Company presented safety, tolerability, pharmacokinetic, and pharmacodynamic data from RUBY-1, a phase 1 study of povetacicept in healthy adult volunteers.

Presentation highlights include:

• In a model of murine experimental autoimmune myasthenia gravis (EAMG), povetacicept treatment initiated after disease onset led to statistically significant reductions, as compared to Fc control treatment, in clinical scores, anti-AChR IgG, and serum Ig.
• 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 studies.

“Together, these data provide strong rationale for the advancement of povetacicept in myasthenia gravis and other autoimmune and/or autoantibody-related neurological conditions,” said Stanford Peng, MD PhD, President and Head of Research and Development at Alpine. “There is a clear need for more safe, efficacious, and conveniently dosed therapies for myasthenia gravis and related diseases, and we look forward to the future opportunity to include them in the povetacicept development program.”

ANA 2023 Poster Presentation Details

Date: September 11, 2023

Poster Title: Povetacicept (ALPN-303), a potent dual BAFF/APRIL antagonist for the treatment of myasthenia gravis and other antibody-related neurological diseases

Poster Number: M135

Link to Poster Presentation: https://bit.ly/3RiIZT1

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 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.

The RUBY and Alpine logos are registered trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230912367677/en/