-- Low-dose povetacicept (80 mg administered
once every four weeks) was well tolerated during subcutaneous
administration and reduced UPCR by greater than 50% in IgA
nephropathy --
-- Higher dose povetacicept (240 mg)
administered once every four weeks currently being explored --
-- Based on this data Alpine will now seek to
begin a pivotal phase 3 IgAN study in the second half of 2024
--
-- Company to host virtual investor call and
webcast today at 4:30 pm ET with James Tumlin, M.D. and Jonathan
Barratt, Ph.D., FRCP --
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 today presented the first clinical data
of povetacicept in autoimmune glomerulonephritis during a
late-breaking poster session at the American Society of Nephrology
(ASN) Kidney Week in Philadelphia, Pennsylvania. In addition, the
Company plans to host an investor event today at 4:30 pm ET.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20231102047423/en/
Figure 1. Clinically Meaningful
Improvements in Proteinuria, Suggesting Remission (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, where povetacicept is administered
subcutaneously (SC) once every four weeks for up to 48 weeks.
Key Highlights from the Late-Breaking ASN Poster
Include:
- As of October 25th, 20 participants with IgA nephropathy (IgAN)
have been enrolled, 12 at the 80 mg dose level, of whom 5 have UPCR
data available at 24 weeks.
- In IgAN, treatment with low-dose povetacicept, 80 mg SC every
four weeks was associated with clinically meaningful improvements
in proteinuria, with a 53.5% reduction from baseline in urine
protein to creatinine ratio (UPCR; n=5) at 24 weeks. In addition,
at 24 weeks, 4/5 (80%) had achieved remission, as defined as UPCR
< 0.5 g/g and ≥50% reduction in UPCR from baseline with stable
renal function (≤ 25% reduction in eGFR from baseline). (Fig.
1)
- In IgAN, treatment with low-dose povetacicept was also
associated with a >60% reduction in the key disease-related
biomarker galactose-deficient IgA1 (Gd-IgA1), as well as stable
renal function as assessed by estimated glomerular filtration rate
(eGFR) (+7.1% from baseline at 24 weeks; n=5).
- The first participant with primary membranous nephropathy
(pMN), also treated with povetacicept 80 mg SC every four weeks,
achieved an immunological remission, defined as a reduction in the
highly disease-relevant biomarker anti-PLA2R1 to an undetectable
level, from a baseline of 209 to < 2 RU/mL by 22 weeks.
- Povetacicept has been well tolerated, with no reported
administration-associated reactions, no instances of IgG < 3
g/L, and no severe infections.
- A higher dose of povetacicept, 240 mg SC every four weeks,
continues to enroll, with initial data expected in 1H 2024.
“In this initial experience, low-dose povetacicept at 80 mg has
been well tolerated and demonstrates highly encouraging
improvements in UPCR and disease biomarkers in IgA nephropathy,
with early evidence suggesting remission," noted James Tumlin,
M.D., Professor of Medicine at Emory University School of Medicine,
Founder and Chief Executive Officer of NephroNet Clinical Trials
Consortium. “These findings suggest a highly compelling development
profile for povetacicept based upon a rapid reduction in the key
pathogenic biomarker Gd-IgA1, marked and clinically meaningful
reductions in UPCR, and a once-a-month dosing regimen. A higher
dose of povetacicept 240 mg every four weeks is currently being
explored and will be of great interest. Further clinical
development of povetacicept in glomerulonephritis, particularly
IgAN, is therefore strongly supported.”
Dr. Tumlin continued, “There remains a significant unmet need
for well-tolerated, convenient, and efficacious therapies in
autoimmune kidney diseases, and dual BAFF/APRIL inhibition has the
potential to be an important disease-modifying mechanism,
especially if considered early in the treatment paradigm.”
“Even at this low 80 mg dose level of povetacicept, the
improvements in proteinuria, accompanied by analogous changes in
Gd-IgA1, are impressive and support its potential to be an
important therapy for IgAN,” remarked Jonathan Barratt, PhD, FRCP,
Mayer Professor of Renal Medicine at the University of Leicester.
“Based on this data, advancement of povetacicept to a pivotal trial
in IgA nephropathy, where it has already accumulated a reasonably
sized clinical experience, seems urgently warranted. The initial
findings in primary membranous nephropathy, a disease with no
approved therapies, are equally encouraging. Further study is
clearly warranted and confirmation of the results in additional pMN
patients, along with correlation with renal outcomes, may
facilitate a rapid development path.”
“These results are the first of what will hopefully be several
data readouts over the next 12-18 months that will help validate
the potential activity of povetacicept across multiple autoimmune
diseases,” noted Stanford Peng, MD, PhD, President and Head of
Research and Development at Alpine. “We eagerly await the initial
data from the next 240 mg dose level in the first half of 2024. In
the meantime, these data support our plan to advance povetacicept
rapidly to a pivotal trial in IgAN, pending regulatory agreement,
in the second half of next year. In addition, we plan to initiate
RUBY-2, a phase 2 study of povetacicept in systemic lupus
erythematosus.”
American Society of Nephrology – Kidney
Week 2023
Date/Time: Thursday, November 2, 2023, 10:00am – 12:00pm
ET Poster Title: Povetacicept, an Enhanced Dual BAFF/APRIL
Antagonist, in Autoantibody-Associated Glomerulonephritis (GN)
Poster Board Number: TH-PO1125 Session Name:
Late-Breaking Posters Location: Exhibit Hall, Pennsylvania
Convention Center, Philadelphia Presenter: James Tumlin,
M.D., Professor of Medicine at Emory University School of Medicine,
Founder and Chief Executive Officer of NephroNet Clinical Trials
Consortium
Investor Conference Call and Webcast
Information
Date/Time: Thursday, November 2, 2023, at 4:30 pm – 5:30
pm ET
Alpine will host a conference call and webcast to discuss the
data update from ASN as well as provide a corporate update. Members
of the Alpine executive team will be joined by James Tumlin, M.D.,
Professor of Medicine at Emory University School of Medicine,
Founder and Chief Executive Officer of NephroNet Clinical Trials
Consortium, and Jonathan Barratt, Ph.D., FRCP, the Mayer Professor
of Renal Medicine at the University of Leicester.
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. 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/2a study of povetacicept in autoimmune
glomerulonephritis, 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 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 progress and
potential of our development programs and product candidates;
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 in 2024; 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;
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 in 2024; 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.
Source: Alpine Immune Sciences, Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231102047423/en/
Media and Investor Relations
Contact: Temre Johnson Alpine Immune Sciences, Inc.
ir@alpineimmunesciences.com media@alpineimmunesciences.com
Alpine Immune Sciences (NASDAQ:ALPN)
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