Alpine Immune Sciences Presents First Preclinical Data for Povetacicept in Myasthenia Gravis at the American Neurological Association Annual Meeting
12 September 2023 - 10:30PM
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 that the Company presented new preclinical data from a
study of povetacicept in a murine experimental autoimmune
myasthenia gravis (EAMG) model during the 148th 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.
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Media and Investor Relations
Contact: Temre Johnson Alpine Immune Sciences, Inc.
ir@alpineimmunesciences.com media@alpineimmunesciences.com
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