Kiniksa Pharmaceuticals Commences Enrollment in Abiprubart Phase 2b Clinical Trial in Sjögren’s Disease
July 09 2024 - 8:00AM
Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA)
(Kiniksa), a commercial-stage biopharmaceutical company with a
pipeline of immune-modulating assets designed to target a spectrum
of cardiovascular and autoimmune diseases, today announced that it
has commenced enrollment of the Phase 2b clinical trial of
abiprubart in Sjögren’s Disease. Abiprubart is an investigational
humanized anti-CD40 monoclonal antibody designed to inhibit
CD40-CD154 (CD40 ligand) interaction.
“Sjögren’s Disease is a debilitating, chronic autoimmune
disorder currently with no FDA-approved therapies. Commencing the
next phase of development of abiprubart in Sjögren’s Disease is an
important step forward for patients,” said Sanj K. Patel, Chairman
and Chief Executive Officer of Kiniksa. “This Phase 2b clinical
trial builds on external mechanistic proof-of-concept as well as
learnings from our own prior clinical data. Additionally, we
believe abiprubart has the potential for differentiation in
addressing unmet need through convenient subcutaneous
administration. Importantly, our current operating plan includes
clinical development of abiprubart in Sjögren’s Disease, and the
company expects to remain cash flow positive on an annual
basis.”
Phase 2b Clinical Trial of Abiprubart in Sjögren’s
DiseaseThe randomized, double-blind, placebo-controlled
Phase 2b clinical trial is designed to evaluate the treatment
response of chronic subcutaneous (SC) administration of abiprubart
in patients with Sjögren’s Disease.
The placebo-controlled portion of the trial will randomize
approximately 201 patients in a 1:1:1 ratio to receive abiprubart
400 mg SC biweekly, 400 mg SC monthly, or placebo over a period of
24 weeks. The primary endpoint is change from baseline in
EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI)
versus placebo at Week 24. Subsequently, patients will enter a
long-term extension in which active treatment will be given in all
study arms for an additional 24 weeks.
About KiniksaKiniksa is a commercial-stage
biopharmaceutical company focused on discovering, acquiring,
developing, and commercializing therapeutic medicines for patients
suffering from debilitating diseases with significant unmet medical
need. Kiniksa’s immune-modulating assets, ARCALYST®, abiprubart,
and mavrilimumab, are based on strong biologic rationale or
validated mechanisms, target a spectrum of underserved
cardiovascular and autoimmune conditions, and offer the potential
for differentiation. For more information, please
visit www.kiniksa.com.
About Abiprubart Abiprubart is an
investigational humanized monoclonal antibody that binds to CD40
and is designed to inhibit the CD40-CD154 (CD40 ligand)
interaction, a key T-cell co-stimulatory signal critical for B-cell
maturation and immunoglobulin class switching and Type 1 immune
responses. Kiniksa believes disrupting the CD40-CD154
co-stimulatory interaction is an attractive approach to addressing
multiple autoimmune disease pathologies.
Forward-Looking StatementsThis press release
contains forward-looking statements. In some cases, you can
identify forward- looking statements by terms such as “may,”
“will,” “should,” “expect,” “plan,” “anticipate,” “could,”
“intend,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “potential” or “continue” or the negative of
these terms or other similar expressions, although not all
forward-looking statements contain these identifying words. All
statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements, including without limitation, statements regarding our
belief that abiprubart has the potential for differentiation in
addressing unmet need through convenient subcutaneous
administration; our expectation to remain cash flow positive on an
annual basis; and our belief that all of our other product
candidates offer the potential for differentiation.
These forward-looking statements are based on management’s
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including without limitation, the
following: delays or difficulty in enrollment of patients in, and
activation or continuation of sites for, our clinical trials;
delays or difficulty in completing our clinical trials as
originally designed; potential for changes between final data and
any preliminary, interim, top-line or other data from clinical
trials; our inability to replicate results from our earlier
clinical trials or studies; impact of additional data from us or
other companies, including the potential for our data to produce
negative, inconclusive or commercially uncompetitive results;
potential undesirable side effects caused by our products and
product candidates; our reliance on third parties to conduct
research, clinical trials, and/or certain regulatory activities for
our product candidates; complications in coordinating requirements,
regulations and guidelines of regulatory authorities across
jurisdictions for our clinical trials; and changes in our operating
plan, business development strategy or funding requirements.
These and other important factors discussed in our filings with
the U.S. Securities and Exchange Commission, including under the
caption “Risk Factors” contained therein, could cause actual
results to differ materially from those indicated by the
forward-looking statements made in this press release. Any such
forward-looking statements represent management’s estimates as of
the date of this press release. Except as required by law, we
disclaim any intention or obligation to update or revise any
forward-looking statements. These forward-looking statements should
not be relied upon as representing our views as of any date
subsequent to the date of this press release.
Every Second Counts! ®
Kiniksa Investor and Media ContactRachel
Frank(339) 970-9437rfrank@kiniksa.com
Kiniksa Pharmaceuticals (NASDAQ:KNSA)
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