Full Press Release Details
Kiniksa Reports Third Quarter 2020 Financial
Results and Highlights Recent Pipeline and Corporate Activity
- November 5, 2020 - 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 reported third quarter 2020 financial results and highlighted recent pipeline and corporate activity.
"Kiniksa continues to execute across its pipeline,"
said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. "We are preparing for the commercial launch
of rilonacept in recurrent pericarditis in the first half of 2021, if approved by the FDA. The primary and secondary efficacy endpoints
of the mavrilimumab Phase 2 trial in giant cell arteritis achieved statistical significance, further demonstrating the potential
broad utility of the molecule. Additionally, all
cohorts have been dosed in the Phase 1 study of KPL-404, our anti-CD40 program, and we expect
data from the first cohorts this quarter."
Rilonacept (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 interaction between
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 product candidates, rilonacept, mavrilimumab, vixarelimab and KPL-404, are based on strong
biologic rationale or validated mechanisms, target underserved conditions, and offer the potential for differentiation. These
pipeline assets are designed to modulate immunological pathways across a spectrum of diseases. For more information, please visit
Rilonacept is a weekly, subcutaneously-injected, recombinant
fusion protein that blocks interleukin-1 alpha (IL-1 ) and interleukin-1 beta (IL-1 ). Rilonacept was discovered and
developed by Regeneron and is approved by the FDA under the brand name ARCALYST for the treatment of Cryopyrin-Associated
Periodic Syndromes (CAPS), specifically Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome. Rilonacept for the treatment
of deficiency of the interleukin1 receptor antagonist (DIRA) is currently pending FDA approval following the submission of a Supplemental
Biologics License Application (sBLA) in June 2020. Rilonacept in recurrent pericarditis is an investigational drug. The FDA
granted Breakthrough Therapy designation to rilonacept for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation
to rilonacept for the treatment of pericarditis in 2020.
Important information about ARCALYST (rilonacept) Injection
IL-1 blockade may interfere with immune response to infections.
Serious, life-threatening infections have been reported in patients taking ARCALYST. ARCALYST should be discontinued if a patient
develops a serious infection. Taking ARCALYST with TNF inhibitors is not recommended because this may increase the risk of serious
Patients should not receive a live vaccine while taking ARCALYST. It is recommended that prior to initiation of therapy with ARCALYST
patients receive all recommended vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine.
In the initial development program for ARCALYST, six serious adverse reactions were reported by four patients: Mycobacterium intracellular
infection, gastrointestinal bleeding and colitis, sinusitis and bronchitis and Streptococcus pneumoniae meningitis. The most commonly
reported adverse reactions associated with ARCALYST were injection site reaction and upper respiratory tract infection. Patients
should be monitored for changes in their lipid profiles and provided with medical treatment if warranted. Treatment with immunosuppressants,
including ARCALYST, may result in an increase in risk of malignancies. Hypersensitivity reactions associated with ARCALYST administration
in clinical studies have been rare. If a hypersensitivity reaction occurs, administration of ARCALYST should be discontinued and
appropriate therapy initiated.
Mavrilimumab is an investigational fully-human monoclonal
antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFR ). Mavrilimumab was dosed
in over 550 patients with rheumatoid arthritis through Phase 2b clinical studies in Europe and achieved
prospectively-defined primary endpoints of efficacy and safety. Kiniksa's lead indication for mavrilimumab is GCA, a
rare inflammatory disease of medium-to-large arteries. Kiniksa is also evaluating mavrilimumab in COVID-19 pneumonia and
hyperinflammation. 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.
KPL-404 is an investigational humanized monoclonal antibody
that is designed to inhibit CD40-CD40L interaction, a key T-cell co-stimulatory signal critical for B-cell maturation and immunoglobulin
class switching. Kiniksa believes disrupting the CD40-CD40L interaction is an attractive approach for blocking T-cell mediated,
B-cell driven responses, drivers of multiple autoimmune disease pathologies such as rheumatoid arthritis, Sjogren's syndrome,
Graves' disease, systemic lupus erythematosus and solid organ transplant.
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: plans and timing of clinical trial data readouts; our beliefs about research, pre-clinical
and clinical trial data supporting continued clinical development; anticipated timing of our potential commercial launch of rilonacept
in recurrent pericarditis, if approved by the FDA under priority review; planned clinical trials and timing thereof, including
a potential dose-ranging Phase 2b clinical trial of vixarelimab in prurigo nodularis; regulatory milestones and related payments
under our License Agreement with Regeneron upon achievement of certain specified events; our beliefs about the potential to bring
rilonacept as a potential treatment option for patients with recurrent pericarditis; our beliefs about the mechanisms of action
of our product candidates and potential impact of their approach; and our projected timeframe for funding our current operating
plan with current cash, cash equivalents and short-term investments.
These forward-looking statements are based on management's
current plans, estimates or 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; potential complications in coordinating among requirements, regulations and guidelines of regulatory authorities
across a number of jurisdictions for our global clinical trials; potential 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
COVID-19 pandemic; potential for low accrual of events in our clinical trials; potential undesirable side effects caused by our
product candidates; our potential inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities
or otherwise producing negative, inconclusive or commercially uncompetitive results; potential for applicable regulatory authorities
to not accept our BLA or sBLA filings or to delay or deny approval of any of our product candidates or to require additional trials
to support any such approval; potential for changes between final data and any preliminary, interim, top-line or other data from
clinical trials conducted by us or third parties, including from investigator initiated studies; impact of additional data from
us or other companies; potential inability to replicate in later clinical trials positive results from earlier pre-clinical and
clinical trials or studies of our product candidates potential in subsequent clinical trials conducted by us or third parties,
including investigator-initiated studies; drug substance and/or drug product shortages; our reliance on third parties as the sole
source of supply of the drug substance and drug products used in our product candidates; our reliance on third parties to conduct
our research, pre-clinical studies, clinical trials, and other trials for our product candidates; substantial existing or new competition;
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 our ability to attract and retain qualified personnel.
These and other important factors discussed under the
caption "Risk Factors" in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission
(SEC) on August 4, 2020 and our other reports subsequently filed with the SEC could cause actual results to differ materially