Full Press Release Details
Kiniksa Pharmaceuticals
Provides Corporate Update
(rilonacept) 2023 net product revenue grew ~90% year-over-year to $233.1 million (unaudited) -
2024 net product revenue expected to be $360 - $380 million -
(KPL-404) Phase 2 rheumatoid arthritis trial met the primary efficacy endpoint in Cohort 3 at the weekly dose level -
Phase 2 rheumatoid arthritis data from Cohort 4 expected in Q2 2024 -
Cash reserves of $206.3 million (unaudited) expected to fund operations into at least 2027-
BERMUDA - January 4, 2024 - 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."
ARCALYST (IL-1 and IL-1
Abiprubart (anti-CD40 monoclonal
antibody inhibitor of CD40-CD154 interaction)
Mavrilimumab (monoclonal antibody
inhibitor targeting GM-CSFR )
Annual J.P. Morgan Healthcare Conference
Kiniksa 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.
a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1 ) and interleukin-1
beta (IL-1 ) 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.
SAFETY INFORMATION ABOUT ARCALYST
more information about ARCALYST, talk to your doctor and see the Product Information.
(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
Phase 2 Clinical Trial of Abiprubart in Rheumatoid Arthritis
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).
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.
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.
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-CSFR ). 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
Forward-Looking Statements
This 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,