Full Press Release Details
Kiniksa Provides Corporate Update and Outlines
Anticipated 2022 Milestones
full-year 2022 guidance to be provided with Q4 2021 financial results -
- Vixarelimab Phase 2b data in prurigo nodularis
expected in 2H 2022 -
- KPL-404 Phase 2 trial in rheumatoid arthritis
now enrolling and dosing patients -
- Year-end 2021 cash reserves expected to fund
current operating plan into 2024 -
- January 10, 2022 - Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company
with a pipeline of assets designed to modulate immunological pathways across a spectrum of diseases, today provided a corporate update
and announced anticipated milestones for 2022.
"2021 was a transformational year for Kiniksa. We progressed
to a commercial-stage company with the successful launch of ARCALYST for the treatment of recurrent pericarditis. We are pleased with
the strong physician and patient adoption and expect to provide annual guidance along with fourth quarter and full-year 2021 financial
results," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "This year, we look forward to continued commercial
excellence with ARCALYST, as well as reporting data from the Phase 2b trial of vixarelimab in prurigo nodularis, and conducting the Phase
2 trial of KPL-404 in rheumatoid arthritis."
ARCALYST (IL-1 and IL-1 cytokine trap)
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFR )
Vixarelimab (monoclonal antibody inhibitor of signaling through
KPL-404 (monoclonal antibody inhibitor of CD40-CD154 signaling)
40th 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 40th Annual J.P. Morgan Healthcare Conference today, Monday, January 10,
2022, at 1:30 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.
Kiniksa is a biopharmaceutical company focused on discovering, acquiring,
developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical
need. Kiniksa's portfolio assets, ARCALYST, mavrilimumab, vixarelimab and KPL-404, are based on strong biologic rationale or validated
mechanisms, target underserved conditions, and offer the potential for differentiation. These assets are designed to modulate immunological
pathways across a spectrum of diseases. For more information, please visit www.kiniksa.com.
ARCALYST is 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 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 designation to ARCALYST for the treatment of pericarditis in 2020.
IMPORTANT SAFETY INFORMATION
For more information
about ARCALYST, talk to your doctor and see the Product Information.
Mavrilimumab is an investigational
fully human monoclonal antibody that blocks activity of granulocyte macrophage colony stimulating factor (GM-CSF) by specifically binding
to the alpha subunit of the GM-CSF receptor. Mavrilimumab was previously evaluated in rheumatoid arthritis through Phase 2b clinical studies
in Europe and achieved prospectively defined primary endpoints of efficacy and safety. Kiniksa is evaluating next steps for mavrilimumab
in giant cell arteritis (GCA). The Phase 2 clinical trial of mavrilimumab in GCA achieved both the primary and secondary efficacy endpoints
with statistical significance. The FDA granted Orphan Drug designation to mavrilimumab for the treatment of GCA in 2020.
Vixarelimab is an investigational
fully human monoclonal antibody that targets oncostatin M receptor beta (OSMR ), which mediates signaling of interleukin-31 (IL-31)
and oncostatin M (OSM), two key cytokines implicated in pruritus, inflammation, and fibrosis. Kiniksa believes vixarelimab to be the
only monoclonal antibody in development that targets both pathways simultaneously. Kiniksa's lead indication for vixarelimab is
prurigo nodularis, a chronic inflammatory skin condition characterized by severely pruritic skin nodules. The FDA granted Breakthrough
Therapy designation to vixarelimab for the treatment of pruritus associated with prurigo nodularis in 2020.
KPL-404 is an investigational
humanized monoclonal antibody that is designed to inhibit 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 interaction
is an attractive approach to address multiple autoimmune disease pathologies. Kiniksa owns or controls the intellectual property related
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 beliefs about the future
commercial demand for ARCALYST; our expectation about our year-end cash reserves and those cash reserves funding our current operating
plan into 2024; expected timing of data from the dose-ranging Phase 2b clinical trial of vixarelimab in prurigo nodularis in the second
half of 2022; our expectation about continued enrollment and dosing of patients in a Phase 2 trial of KPL-404 in rheumatoid arthritis;
our belief in the potential broad utility of mavrilimumab and our expectations regarding our next steps for mavrilimumab, including in
giant cell arteritis; our belief that KPL-404 has broad utility across multiple indications; our beliefs about the mechanisms of action
of our product candidates and potential impact of their approach, including that vixarelimab is the only monoclonal antibody in development
that targets both interleukin-31 (IL-31) and oncostatin M (OSM) pathways simultaneously and that disrupting the CD40-CD154 interaction
is an attractive approach to address multiple autoimmune disease pathologies; our belief that all of our product candidates offer the
potential for differentiation; and our plans to present at any future conferences.
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; amendments to our clinical trial protocols
initiated by us or required by regulatory authorities; delays or difficulty in completing our clinical trials, including as a result of
the ongoing COVID-19 pandemic; potential for changes between final data and any preliminary, interim, top-line or other data from clinical
trials conducted by us or third parties; our inability to replicate in later clinical trials the positive final data 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 or to delay or deny approval of any of our product candidates or to require additional data or trials
to support any such approval; delays, difficulty or 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 products used in our products and product candidates; our
reliance on Regeneron as the sole manufacturer of ARCALYST; raw materials, 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; the impact
of the COVID-19 pandemic and measures taken in response to the pandemic on our business and operations as well as the business and operations
of our manufacturers, CROs upon whom we rely to conduct our clinical trials, and other third parties with whom we conduct business or
otherwise engage, including the FDA and other regulatory authorities; changes in our operating plan and funding requirements; and existing
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