Alpine Immune Sciences Announces Initiation of Dosing in 240 mg IgA Nephropathy Cohort of Povetacicept Clinical Study (RUBY-3)
31 August 2023 - 6:30AM
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 successful initiation of the second IgA nephropathy
(IgAN) dose cohort in RUBY-3, a phase 1b/2a study in autoimmune
glomerulonephritis.
- Safety Monitoring Committee (SMC) review has determined that
repeat dosing of povetacicept in the first IgAN dose cohort (80 mg
subcutaneously once every 4 weeks) has been safe and well-tolerated
to date, with no serious or severe adverse events, no events of
hypogammaglobulinemia (IgG < 3g/L), and no instances of
hypersensitivity or administration-related reactions.
- Dose escalation has been endorsed, and enrollment of the second
IgAN dose cohort (240 mg subcutaneously every 4 weeks) has been
initiated.
“We are encouraged by this first in-disease experience with the
lowest dose level of povetacicept in this study, confirming its
initial safety and pharmacodynamic activity during multiple dose
administration,” noted Stanford Peng, President and Head of
Research and Development at Alpine. “We look forward to providing
more detailed clinical updates later this year in appropriate
scientific forums.”
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 RUBY-3
RUBY-3 (NCT05732402) is a multiple ascending dose, multi-cohort,
open label, phase 1b/2a study of povetacicept in IgA nephropathy,
lupus nephritis, and primary membranous nephropathy, where
povetacicept is being administered subcutaneously for up to 48
weeks. Key endpoints include proteinuria, eGFR, renal response, and
disease-related autoantibodies.
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, potential therapies, and product candidates,
including those regarding our future development plans.
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, may be more severe and prolonged than currently
anticipated; 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.
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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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