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 provided a corporate
update.
"Strong execution to date has laid the foundation for the
continued advancement of Kiniksa’s portfolio in 2024. ARCALYST 2023
net product revenue grew ~90% year-over-year to $233.1 million,
underscoring our robust commercial performance. We believe there is
substantial opportunity with ARCALYST in recurrent pericarditis and
expect to drive continued revenue growth and collaboration
profitability by reaching an increasing number of patients. In
fact, at the end of 2023 Kiniksa penetrated approximately 9% into
the multiple-recurrence population, compared to approximately 5% at
the end of 2022,” said Sanj K. Patel, Chairman and Chief Executive
Officer of Kiniksa. “Additionally, abiprubart showed clinical
effect in the first three cohorts of the Phase 2 trial in
rheumatoid arthritis. Despite a high placebo response rate, the 5
mg/kg weekly dose level in Cohort 3 achieved statistical
significance, but the 5 mg/kg biweekly dose level did not. We look
forward to evaluating results from Cohort 4, and we will use the
totality of the data to determine next steps for the program.
Importantly, our strong financial position provides optionality to
continue to invest across our business, including ARCALYST
commercialization as well as both pipeline and business
development.”
Portfolio ExecutionARCALYST (IL-1α and
IL-1β cytokine trap)
- ARCALYST net product revenue was $71.2 million and $233.1
million for the fourth quarter and full year 2023, respectively
(unaudited).
- Since launch in April 2021, more than 1,700 prescribers have
written ARCALYST prescriptions for recurrent pericarditis.
- As of the end of the fourth quarter of 2023, average total
duration of ARCALYST therapy in recurrent pericarditis increased to
approximately 23 months.
- As of the end of the fourth quarter of 2023, approximately 9%
of the target 14,000 multiple-recurrence patients were actively on
ARCALYST treatment.
- Kiniksa increased the size of its salesforce to approximately
85 representatives by the end of 2023 to help drive further
physician adoption and patient enrollments in 2024.
- Kiniksa expects 2024 ARCALYST net product revenue of between
$360 million and $380 million.
Abiprubart (anti-CD40 monoclonal antibody inhibitor of
CD40-CD154 interaction)
- Kiniksa today announced that the Phase 2 clinical trial of
abiprubart in rheumatoid arthritis met its primary efficacy
endpoint, change from baseline in Disease Activity Score of 28
Joints Using C-reactive Protein (DAS28-CRP) versus placebo.
- In Cohorts 1 and 2 (pharmacokinetic (PK)-lead in), multiple
doses of abiprubart were well-tolerated and enabled the
proof-of-concept portion of the study. Although these cohorts were
not powered for DAS28-CRP (Secondary Efficacy Endpoint), the
following results were observed:
- In Cohort 1, in the abiprubart 2 mg/kg subcutaneous (SC)
biweekly dosing group (n=6), the mean change from baseline in
DAS28-CRP at Week 12 was -3.16 points compared to -1.09 points in
pooled placebo recipients (n=4), (Mean Difference = -2.07,
p=0.0312).
- In Cohort 2, in the abiprubart 5 mg/kg SC biweekly dosing group
(n=6), the mean change from baseline in DAS28-CRP at Week 12 was
-3.44 points compared to pooled placebo recipients (n=4), (Mean
Difference = -2.35, p=0.0338).
- In Cohort 3, in the abiprubart 5 mg/kg SC weekly dosing group
(n=27), the Least Squares (LS) mean change [95% confidence interval
(CI)] from baseline in DAS28-CRP at Week 12 was -2.21 [-2.62,
-1.80] points compared to -1.65 [-2.07, -1.23] points in placebo
recipients (n=26), (LS Mean Difference = -0.56, p=0.0487).
- In Cohort 3, in the abiprubart 5 mg/kg SC biweekly dosing group
(n=25), the LS mean change [95% CI] from baseline in DAS28-CRP at
Week 12 was -2.00 [-2.43, -1.58] points compared to -1.65 [-2.07,
-1.23] points in placebo recipients (n=26), (LS Mean
Difference = -0.35, p=0.2140).
- Abiprubart significantly reduced Rheumatoid Factor (a clinical
marker of disease activity and autoantibody pharmacodynamic marker
of CD40 target engagement) by over 40% in both Cohort 3 dose
levels.
- Abiprubart was well-tolerated, with no dose-related adverse
experiences observed.
- Kiniksa has now completed enrollment in a fourth cohort (Cohort
4) of the Phase 2 clinical trial of abiprubart in rheumatoid
arthritis. Cohort 4 will evaluate a fixed dose level administered
as a single subcutaneous injection once monthly. The company
expects data from Cohort 4 in the second quarter of 2024.
Mavrilimumab (monoclonal antibody inhibitor targeting
GM-CSFRα)
- Kiniksa is now evaluating potential partnership opportunities
to advance development of mavrilimumab, which has generated
positive data in mid-stage clinical trials across multiple
indications.
Corporate Update
- Kiniksa’s year-end 2023 cash, cash equivalents, and short-term
investments of $206.3 million (unaudited) are expected to fund its
current operating plan into at least 2027.
42nd Annual J.P.
Morgan Healthcare Conference
- Sanj K. Patel, Chief Executive Officer and Chairman of
the Board of Kiniksa will provide a corporate presentation at
the 42nd Annual J.P. Morgan Healthcare Conference on January 8,
2024, at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time). A live
webcast of Kiniksa’s presentation will be accessible through the
Investors & Media section of the company’s website
at www.kiniksa.com. A replay of the webcast will also be
available on Kiniksa’s website within approximately 48 hours after
the event.
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 ARCALYSTARCALYST is a weekly,
subcutaneously injected recombinant dimeric fusion protein that
blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β)
signaling. ARCALYST was discovered by Regeneron Pharmaceuticals,
Inc. (Regeneron) and is approved by the U.S. Food and Drug
Administration (FDA) for recurrent pericarditis,
cryopyrin-associated periodic syndromes (CAPS), including Familial
Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and
deficiency of IL-1 receptor antagonist (DIRA). The FDA granted
Breakthrough Therapy designation to ARCALYST for the treatment of
recurrent pericarditis in 2019 and Orphan Drug exclusivity to
ARCALYST in 2021 for the treatment of recurrent pericarditis and
reduction in risk of recurrence in adults and pediatric patients 12
years and older. The European Commission granted Orphan Drug
Designation to ARCALYST for the treatment of idiopathic
pericarditis in 2021.
IMPORTANT SAFETY INFORMATION ABOUT ARCALYST
- ARCALYST may affect your immune system and can lower the
ability of your immune system to fight infections. Serious
infections, including life-threatening infections and death, have
happened in patients taking ARCALYST. If you have any signs of an
infection, call your doctor right away. Treatment with ARCALYST
should be stopped if you get a serious infection. You should not
begin treatment with ARCALYST if you have an infection or have
infections that keep coming back (chronic infection).
- While taking ARCALYST, do not take other medicines that block
interleukin-1, such as Kineret® (anakinra), or medicines that block
tumor necrosis factor, such as Enbrel® (etanercept), Humira®
(adalimumab), or Remicade® (infliximab), as this may increase your
risk of getting a serious infection.
- Talk with your doctor about your vaccine history. Ask your
doctor whether you should receive any vaccines before you begin
treatment with ARCALYST.
- Medicines that affect the immune system may increase the risk
of getting cancer.
- Stop taking ARCALYST and call your doctor or get emergency care
right away if you have any symptoms of an allergic reaction.
- Your doctor will do blood tests to check for changes in your
blood cholesterol and triglycerides.
- Common side effects include injection-site reactions (which may
include pain, redness, swelling, itching, bruising, lumps,
inflammation, skin rash, blisters, warmth, and bleeding at the
injection site), upper respiratory tract infections, joint and
muscle aches, rash, ear infection, sore throat, and runny
nose.
For more information about ARCALYST, talk to your doctor
and see the Product
Information.
About Abiprubart (KPL-404)Abiprubart (KPL-404)
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 is a randomized, double-blind, placebo-controlled
trial designed to evaluate pharmacokinetics, safety, and efficacy
of chronic subcutaneous 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
Janus kinase inhibitor (JAKi) or at least one biologic
disease-modifying anti-rheumatic drug (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
pharmacokinetics, 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 is change from baseline in
DAS28-CRP versus placebo.
About MavrilimumabMavrilimumab is an
investigational fully human monoclonal antibody that blocks
activity of GM-CSF by specifically binding to the alpha subunit of
the GM-CSF receptor (GM-CSFRα). Phase 2 clinical trials of
mavrilimumab in rheumatoid arthritis and giant cell arteritis
achieved their primary and secondary endpoints with statistical
significance. Kiniksa is now evaluating potential partnership
opportunities for mavrilimumab.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. 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
expectation that ARCALYST 2024 net product revenue will be between
$360 million and $380 million; our plan to report data from Cohort
4 of our Phase 2 clinical trial of abiprubart in rheumatoid
arthritis in the second quarter of 2024; our expectation about our
cash reserves funding our current operating plan into at least
2027; our expectation that we will drive continued ARCALYST revenue
growth and collaboration profitability by reaching an increasing
number of patients; 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; inability to
successfully execute on our commercial strategy for ARCALYST; our
reliance on third parties as the sole source of supply of the drug
substance and drug product used in our products and product
candidates; our reliance on Regeneron as the current sole
manufacturer of ARCALYST; risks arising from our ongoing technology
transfer of ARCALYST drug substance manufacturing; 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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