-- Povetacicept administered subcutaneously
once every four weeks continues to be well tolerated in IgA
nephropathy, with UPCR reductions of greater than 60% observed at
36 weeks, associated with remission, resolution of hematuria, and
stable renal function (eGFR) --
-- Company reports successful end of phase 2
meeting with FDA, supporting advancement to a registrational,
placebo-controlled phase 3 study of povetacicept in IgA
nephropathy, targeted in 2H 2024 --
-- Company will host an investor call and
webcast today at 5:15 pm ET --
Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading
clinical-stage immunotherapy company focused on developing
innovative treatments for autoimmune and inflammatory diseases,
today shared updated clinical data for povetacicept in IgA
nephropathy (IgAN) which will be presented as a late breaking
poster at the World Congress of Nephrology (WCN) April 13-16, 2024
in Buenos Aires, Argentina.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240410724204/en/
Figure 1. Povetacicept is Associated with
Clinically Meaningful UPCR Reductions, Stable eGFR in IgA
Nephropathy, and Reductions in Gd-IgA1 and Gd-IgA1/C3 Ratio
(Graphic: Business Wire)
Povetacicept is a potent 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. RUBY-3 is a multiple ascending dose, multi-cohort, open
label, phase 1b/2a study of povetacicept in autoimmune
glomerulonephritis, including IgA nephropathy, where povetacicept
is administered subcutaneously (SC) once every four weeks.
Key Highlights Include:
- As of March 01, 2024, 41 patients with IgAN had received
povetacicept 80 or 240 mg subcutaneously every 4 weeks. Treatment
with povetacicept 80 mg SC Q4W has been associated with a
clinically meaningful improvement in proteinuria, with a 64.1%
reduction from baseline in urine protein to creatinine ratio (UPCR;
n=6) at 36 weeks, associated with stable renal function as assessed
by estimated glomerular filtration rate (eGFR). At this same time,
4/6 (67%) had achieved remission, as defined as UPCR < 0.5 g/g,
≥50% reduction in UPCR from baseline, and stable renal function (≤
25% reduction in eGFR from baseline).
- Resolution of hematuria, as defined as negative or trace/small
hematuria in patients with non-negative/trace hematuria at
baseline, was achieved in all (100%) patients with data available
at 36 or more weeks (N=4).
- Treatment with povetacicept 240 mg SC Q4W has been associated
with similar improvements in proteinuria, stable renal function,
and remission, based on initial data through 12 (13 patients) and
24 (2 patients) weeks.
- Treatment with both doses was associated with significant
reductions in the key disease-related biomarker Gd-IgA1, with the
80 mg dose achieving a 68.9% reduction at 40 weeks, and the 240 mg
dose achieving a 78.6% reduction at 20 weeks. Both doses achieved
reductions in IgA/C3 and Gd-IgA1/C3 ratios, which are additional
severity and prognostic biomarkers in IgAN.
- Both doses have been well tolerated in IgAN, with no instances
of IgG < 3 g/L and no severe infections.
“These updated findings for povetacicept are highly promising
and continue to support the potential for the program as an
important new therapy in IgA nephropathy,” noted Jonathan Barratt,
M.D., the Mayer Professor of Renal Medicine and Honorary Consultant
Nephrologist and IgA Nephropathy Rare Disease Group Lead,
University of Leicester. “The marked and clinically meaningful
improvement in UPCR and stable eGFR observed with a monthly dosing
regimen at 36 weeks are particularly impressive, as are the deep
reductions in Gd-IgA1, a key disease-related biomarker, and
resolution of hematuria in patients. The lack of serious adverse
events with longer duration of treatment and higher dose is also
notable and, together with povetacicept’s disease modifying
potential and substantial patient experience, strongly supports the
rapid advancement of povetacicept into a pivotal study for IgA
nephropathy.”
“Despite advancements in IgA nephropathy, there remains an
urgent need for safe and convenient therapies that effectively
treat the underlying cause of the disease,” said James Tumlin,
M.D., Professor of Medicine at Emory University School of Medicine,
Founder and CEO of NephroNet Clinical Trials Consortium. “Dual
APRIL/BAFF inhibition is a potent inhibitor of Galactose Deficient
IgA1 (Gd-IgA1) production which is closely linked to the
pathogenesis and progression of IgA nephropathy. Monthly
administration of povetacicept has been shown to be well-tolerated
at both the 80mg and 240 mg doses with clinical responses including
Gd-IgA1, urine protein levels and eGFR stabilization within 3
months. These data strongly support the inhibition of APRIL/BAFF
pathways by povetacicept and its efficacy in the treatment of IgAN
as well as the need for further clinical development. If approved,
povetacicept could be used a front-line disease modifying treatment
in IgAN.”
“These data indeed continue to further our enthusiasm for the
potential of povetacicept in IgAN and other autoimmune diseases,”
remarked Stanford Peng, MD PhD, President and Head of Research and
Development at Alpine. “We are pleased to have completed our
successful end of phase 2 meeting with FDA, enabling advancement to
a registrational trial in IgAN (RAINIER) later this year. In
addition, we plan to continue to explore povetacicept’s potential
in multiple other autoimmune diseases via the ongoing RUBY-3 and
RUBY-4 studies, and via the initiation of a phase 2 study (DENALI)
in systemic lupus erythematosus later this year.”
World Congress of Nephrology
Late-Breaking Poster
Date/Time: Monday, April 15, 2024, 5:45 pm local time
(GMT-3) /4:45 pm ET/1:45 pm PT Poster Title: Updated Results
from the RUBY-3 study of Povetacicept, an Enhanced Dual BAFF/APRIL
Antagonist in IgA Nephropathy Poster Number: MON-304
Session Name: Poster Session 3 (Late Breaking)
Location: Exhibition Hall and Main Foyer, Buenos Aires
Convention Center, Buenos Aires, Argentina Presenter: James
Tumlin, M.D., Professor of Medicine at Emory University School of
Medicine, Founder and CEO of NephroNet Clinical Trials
Consortium
Alpine will host an investor call and webcast to discuss the
data update as well as provide a corporate update.
The link to the webcast is available in the investor relations
section of the Company’s website at
https://ir.alpineimmunesciences.com/events and a replay will be
available on the Company's website for 90 days following the live
event.
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 other inhibitors of BAFF and/or APRIL
alone and B cell depletion and has demonstrated initial activity in
patients with IgA nephropathy. Povetacicept is in development for
multiple autoimmune diseases, including IgA nephropathy and other
autoimmune kidney diseases, systemic lupus erythematosus, and
autoimmune cytopenias.
About RUBY-3
RUBY-3 (NCT05732402) is a multiple ascending dose, multi-cohort,
open label, phase 1b/2 study of povetacicept in autoimmune
glomerulonephritis, including IgA nephropathy, primary membranous
nephropathy, lupus nephritis, and renal ANCA-associated vasculitis,
where povetacicept is being administered subcutaneously for up to
104 weeks. Key endpoints include proteinuria, eGFR, renal response,
and disease-related autoantibodies.
About RUBY-4
RUBY-4 (NCT05757570) is a multi-cohort, open label study of
povetacicept in autoimmune cytopenias, including immune
thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin
disease, where povetacicept is being administered subcutaneously
for up to 48 weeks. Key endpoints include respective blood cell
counts, durable responses, as well as disease-related
autoantibodies.
About RAINIER
RAINIER is an upcoming, randomized, double-blind,
placebo-controlled, pivotal phase 3 study to evaluate the safety
and efficacy of povetacicept in patients with IgA nephropathy at
risk of progression to kidney failure.
About DENALI
DENALI is an upcoming, randomized, double-blind,
placebo-controlled phase 2 study to evaluate the safety and
efficacy of povetacicept in patients with active systemic lupus
erythematosus.
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 X
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, including
cash equivalents and restricted cash, and investments to fund our
planned operations; our ability to achieve additional milestones in
our collaborations and proprietary programs; the progress and
potential of our development programs; future development plans and
clinical and regulatory milestones and objectives, including the
timing and achievement thereof; the efficacy of our clinical trial
designs; anticipated enrollment in our clinical trials and the
timing thereof; expectations regarding the anticipated reporting of
data from our ongoing and planned clinical trials and potential
publication of future clinical data; our ability to potentially
advance povetacicept directly into a pivotal trial as well as a
phase 2 study in systemic lupus erythematosus, and the potential
efficacy, safety profile, addressable market, regulatory success
and commercial or therapeutic potential of our product candidates.
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; we may be
unable to advance povetacicept directly into a pivotal trial or a
phase 2 study in systemic lupus erythematosus; 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.
Additional Information about the Acquisition (the offer) of
Alpine by Vertex Pharmaceuticals Incorporated (Vertex) and Where to
Find It
The offer has not yet commenced. This press release is for
informational purposes only, is not a recommendation and is neither
an offer to purchase nor a solicitation of an offer to sell any
securities, nor is it a substitute for the tender offer materials
that Vertex and the Purchaser will file with the SEC upon
commencement of the offer. A solicitation and offer to buy
outstanding shares of Alpine will only be made pursuant to the
tender offer materials that Vertex and the Purchaser intend to file
with the SEC. At the time the offer is commenced, Vertex and the
Purchaser will file with the SEC tender offer materials on Schedule
TO, and Alpine will file with the SEC a Solicitation/Recommendation
Statement on Schedule 14D-9 with respect to the offer.
THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A
RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER
DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL
CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND
THE PARTIES THERETO. INVESTORS AND STOCKHOLDERS OF ALPINE ARE URGED
TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE (AND
EACH AS IT MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME),
BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND
STOCKHOLDERS OF ALPINE SHOULD CONSIDER BEFORE MAKING ANY DECISION
REGARDING TENDERING THEIR SHARES OF COMMON STOCK IN THE OFFER. The
tender offer materials (including the Offer to Purchase and the
related Letter of Transmittal) will be made available to all
stockholders of Alpine at no expense to them under the “Investors”
section of Vertex’s website at
https://investors.vrtx.com/financial-information/sec-filings or by
email at Investorinfo@VRTX.com, or by directing requests for such
materials to the information agent for the offer, which will be
named in the tender offer materials, and (once they become
available) the tender offer materials as well as the
Solicitation/Recommendation Statement will be mailed to the
stockholders of Alpine free of charge. Copies of the documents
filed with the SEC by Alpine will be available free of charge on
Alpine’s website, ir.alpineimmunesciences.com, or by contacting
Alpine’s investor relations department at
ir@alpineimmunesciences.com. The information contained in, or that
can be accessed through, Vertex’s website and Alpine’s website is
not a part of or incorporated by reference herein. The tender offer
materials (including the Offer to Purchase and the related Letter
of Transmittal), as well as the Solicitation/Recommendation
Statement, will also be made available for free on the SEC’s
website at www.sec.gov. In addition to the Offer to Purchase, the
related Letter of Transmittal and certain other tender offer
documents, as well as the Solicitation/Recommendation Statement,
Vertex and Alpine file annual, quarterly, and current reports,
proxy statements, and other information with the SEC. You may read
any reports, statements, or other information filed by Vertex and
Alpine with the SEC for free on the SEC’s website at
www.sec.gov.
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Media and Investor Relations
Contact: Alpine Immune Sciences, Inc.
ir@alpineimmunesciences.com media@alpineimmunesciences.com
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