Kiniksa Pharmaceuticals, Ltd. (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 plans to
initiate a Phase 2b trial with abiprubart in Sjogren’s Disease.
Additionally, the company announced data from Cohort 4 of the Phase
2 clinical trial of abiprubart in rheumatoid arthritis. Abiprubart
is an investigational humanized anti-CD40 monoclonal antibody
designed to inhibit CD40-CD154 (CD40 ligand) interaction.
“We believe abiprubart has the potential to provide meaningful
benefit to patients suffering from Sjogren’s Disease, a
debilitating disorder with no current FDA-approved therapies. Based
on the clear biological activity demonstrated by abiprubart,
potential for convenient subcutaneous administration, and external
proof-of-concept of inhibition of the CD40-CD154 interaction, we
plan to initiate a Phase 2b trial of abiprubart in Sjogren’s
Disease in the second half of 2024,” said Sanj K. Patel, Chairman
and Chief Executive Officer of Kiniksa. “Supported by our robust
ARCALYST revenue growth and current cash position, we continue to
execute a strategic and disciplined capital allocation approach in
areas we believe provide the best opportunity to drive
long-term value. Based on our current operating plan, which
includes advancement of abiprubart through Phase 3 development in
Sjogren’s Disease, we expect to remain cash flow positive on an
annual basis.”
Phase 2b Clinical Trial of Abiprubart in Sjogren’s
DiseaseKiniksa is planning to initiate a randomized,
double-blind, placebo-controlled Phase 2b trial designed to
evaluate the treatment response of chronic subcutaneous (SC)
administration of abiprubart in patients with Sjogren’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 will be change from baseline in
EULAR Sjogren’s Syndrome Disease Activity Index (ESSDAI)
versus placebo at Week 24. Subsequently, patients will enter a
long-term extension in which all patients will receive active
treatment for an additional 24 weeks. The trial is expected to
initiate in the second half of 2024.
Abiprubart Phase 2 Rheumatoid Arthritis DataThe
Phase 2 rheumatoid arthritis trial uses a randomized, double-blind,
placebo-controlled design to evaluate pharmacokinetics (PK),
safety, and efficacy of chronic SC administration of abiprubart and
to provide optionality to evaluate abiprubart across a range of
autoimmune diseases. The trial enrolled patients with active
rheumatoid arthritis who had an inadequate response or were
intolerant to a Janus kinase inhibitor (JAKi) or at least one
biologic disease-modifying anti-rheumatic drug (bDMARD).
Following previously reported topline data, Kiniksa today
announced final data from the first three cohorts of the clinical
trial:
- In Cohorts 1 and 2, multiple doses of abiprubart were
well-tolerated and enabled the proof-of-concept portion of the
study.
- In the Cohort 3 abiprubart 5 mg/kg SC weekly dose group (n=27),
the Least Squares (LS) mean change [95% confidence interval (CI)]
from baseline in Disease Activity Score of 28 Joints Using
C-reactive Protein (DAS28-CRP) at Week 12 was -2.17 [-2.60, -1.74]
points, compared to -1.61 [-2.04, -1.17] points in placebo
recipients (n=26), (LS Mean Difference = -0.57, p=0.0470).
- In the Cohort 3 abiprubart 5 mg/kg SC biweekly dose group
(n=25), the LS mean change [95% CI] from baseline in DAS28-CRP at
Week 12 was -1.96 [-2.40, -1.52] points, compared to -1.61 [-2.04,
-1.17] points in placebo recipients (n=26), (LS Mean Difference =
-0.36, p=0.2124).
- There was a statistically significant reduction of over 40% in
Rheumatoid Factor, a clinical marker of disease activity and an
autoantibody pharmacodynamic marker of CD40 target engagement, in
both Cohort 3 abiprubart dose groups (p<0.0001).
- Abiprubart was well-tolerated, with no dose-related adverse
experiences observed.
Today, Kiniksa announced topline data from the fourth cohort of
the clinical trial:
- In the Cohort 4 abiprubart 400 mg SC monthly dose group (n=31),
the LS mean change [95% CI] from baseline in DAS28-CRP at Week 12
was -1.87 [-2.54, -1.21] points, compared to -1.30 [-1.98, -0.62]
points in placebo recipients (n=20), (LS Mean Difference =
-0.58, p=0.109).
- There was a statistically significant reduction of
approximately 40% in Rheumatoid Factor in the abiprubart group
(p=0.0003).
- As in the first three cohorts, abiprubart was well-tolerated,
and no dose-related adverse experiences were observed.
Additionally, Kiniksa today announced a post-hoc analysis of
data pooled from the Cohort 3 and Cohort 4 abiprubart and placebo
groups:
- In the pooled abiprubart group (n=83), the LS mean change [95%
CI] from baseline in DAS28-CRP at Week 12 was -2.04 [-2.34, -1.74]
points, compared to -1.52 [-1.88, -1.16] points in placebo
recipients (n=46), (LS Mean Difference = -0.52, nominal
p=0.010).
“These Phase 2 data demonstrate that abiprubart is a potentially
efficacious and well-tolerated therapeutic approach for multiple
autoimmune diseases, including Sjogren’s Disease,” said John
F. Paolini, MD, PhD, Chief Medical Officer of Kiniksa. “The
comparable magnitude of reduction in Rheumatoid Factor observed
across weekly, biweekly, and monthly dosing and supportive post-hoc
analysis of pooled efficacy data reinforce our confidence that
abiprubart is highly active. We look forward to initiating the
Phase 2b trial in Sjogren’s Disease in the second half of this
year.”
Financial GuidanceKiniksa expects to remain
cash flow positive on an annual basis within its current operating
plan, which includes advancement of abiprubart through Phase 3
development in Sjogren’s Disease.
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.
About the Phase 2 Clinical Trial of Abiprubart in
Rheumatoid ArthritisThe ongoing Phase 2 rheumatoid
arthritis trial uses a randomized, double-blind, placebo-controlled
design to evaluate PK, safety, and efficacy of chronic SC
administration of abiprubart and to provide optionality to evaluate
abiprubart across a range of autoimmune diseases. This trial
enrolled patients with active rheumatoid arthritis who had an
inadequate response or were intolerant to a JAKi or at least one
bDMARD.
The multiple ascending-dose PK lead-in portion randomized 8
patients each in a 3:1 ratio to receive abiprubart 2 mg/kg or
placebo (Cohort 1) or 5 mg/kg or placebo (Cohort 2), administered
subcutaneously biweekly over a period of 12 weeks. The primary
objective of this part of the trial was to evaluate PK, safety, and
tolerability over 12 weeks. The secondary efficacy endpoint was
change from baseline in DAS28-CRP versus placebo.
The first part of the proof-of-concept portion of the trial
(Cohort 3) randomized 78 patients in a 1:1:1 ratio to receive
abiprubart 5 mg/kg SC weekly, abiprubart 5 mg/kg SC biweekly, or
placebo over a period of 12 weeks. The final part of the
proof-of-concept portion of the trial (Cohort 4) randomized 51
patients in a 3:2 ratio to receive a fixed 600 mg loading dose on
Day 1 followed by 400 mg SC every four weeks or placebo over a
period of 12 weeks. The primary efficacy endpoint of the
proof-of-concept portion of the trial was change from baseline in
DAS28-CRP versus placebo.
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 plan to
initiate a Phase 2b clinical trial of abiprubart in Sjogren’s
Disease in the second half of 2024; our expectation that abiprubart
development in Sjogren’s Disease will remain fully funded through
Phase 3 development; our expectation to advance abiprubart through
Phase 3 development in Sjogren’s Disease; our expectation to remain
cash flow positive on an annual basis within our current operating
plan; our expectation that our capital allocation will provide the
best opportunity to drive long-term value; our expectations around
the possibility of achieving meaningful effect and differentiation
via subcutaneous administration with abiprubart; future clinical
trial design, including the design of our planned Phase 2b trial of
abiprubart in Sjogren’s Disease; our beliefs about the mechanisms
of our product candidates and potential impact of their approach,
including that using abiprubart to disrupt the CD40-CD154
co-stimulatory interaction is an attractive approach to address
multiple autoimmune disease pathologies; and our belief that all of
our 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 inability to demonstrate safety and
efficacy to the satisfaction of applicable regulatory authorities;
potential for applicable regulatory authorities to not accept our
filings, delay or deny approval of any of our product candidates or
require additional data or trials to support approval; our reliance
on third parties as the sole source of supply of the drug substance
and drug product used in our product candidates; raw material,
important ancillary product and drug substance and/or drug product
shortages; 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; changes in our operating
plan, business development strategy or funding requirements; and
existing or new competition.
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.
ARCALYST is a registered trademark of Regeneron. All other
trademarks are the property of their respective owners.
Every Second Counts! ®
Kiniksa Investor and Media ContactRachel
Frank(339) 970-9437rfrank@kiniksa.com
Kiniksa Pharmaceuticals (NASDAQ:KNSA)
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