Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a
biopharmaceutical company focused on discovering, acquiring,
developing and commercializing therapeutic medicines for patients
with significant unmet medical need, presented findings from a
real-world patient survey assessing the substantial impact of
recurrent pericarditis on health-related quality of life at ESC
Congress 2020, the annual meeting of the European Society of
Cardiology.
“The results of the patient survey highlight the severe and
complex impact of recurrent pericarditis on both physical and
mental quality of life. Furthermore, this study highlights the
unmet need for a therapy that can rapidly resolve pericarditis
episodes with the potential to prevent future recurrences,”
said Qasim Rizvi, Chief Commercial Officer and SVP of
Operations at Kiniksa. “The pivotal Phase 3 trial of rilonacept in
recurrent pericarditis demonstrated a high degree of statistical
significance on the primary and all major secondary endpoints,
therefore we plan to submit an sBLA to the FDA in recurrent
pericarditis this year. In preparation for commercialization we are
continuing to generate additional evidence on the burden of
recurrent pericarditis and also increasing disease awareness among
payers, physicians and advocacy groups. We look forward to bringing
this potential treatment to patients as soon as possible.”
Martin LeWinter, MD, Larner College of Medicine, University of
Vermont, was the lead author of the virtual poster Clinical
Characteristics and Health-Related Quality of Life of Patients with
Recurrent Pericarditis in the United States: Findings from a
Patient Survey. The materials are available through the Science
section of Kiniksa’s website (www.Kiniksa.com).
“This study represents the first real-world analysis of
patient-reported health-related quality of life in recurrent
pericarditis,” said Martin LeWinter, MD, Larner College of
Medicine, University of Vermont. “Quantifying the impact of
recurrent pericarditis on important health-related quality of life
measures, including physical and emotional well-being, has enabled
a more complete appreciation of the overall burden of recurrent
pericarditis. For example, we found that pericarditis pain
significantly impacts the ability to work, to be with family
members, and to sleep for many patients at a level greater than
that reported for many other debilitating diseases. These insights
can help clinicians and patients evaluate treatment options and
ultimately may contribute to improving outcomes.”
Kiniksa reported positive data from RHAPSODY, a global,
randomized withdrawal design, pivotal Phase 3 clinical trial of
rilonacept in recurrent pericarditis. RHAPSODY showed that
rilonacept improved clinically meaningful outcomes associated with
the unmet medical need in recurrent pericarditis for patients in
the study. The primary efficacy endpoint of time-to-first
adjudicated pericarditis recurrence in the randomized withdrawal
period was highly statistically significant: rilonacept treatment
resulted in a 96% reduction in risk of recurrent pericarditis
events (Hazard Ratio = 0.04, p<0.0001). All major secondary
endpoints were also highly statistically significant.
Rilonacept was discovered and developed by Regeneron
Pharmaceuticals, Inc. (Regeneron) and is approved by the U.S. Food
and Drug Administration (FDA) under the brand name ARCALYST® for
the treatment of for Cryopyrin-Associated Periodic Syndromes
(CAPS). Kiniksa licensed rilonacept from Regeneron in 2017 for
evaluation in diseases believed to be mediated by both
interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β),
including recurrent pericarditis. The FDA granted Breakthrough
Therapy designation to rilonacept for recurrent pericarditis in
2019 and Orphan Drug designation to rilonacept for pericarditis in
2020. Based on the Phase 3 RHAPSODY data, the Biologic License
Application (BLA) for CAPS will transfer to Kiniksa, and the
company plans to submit a supplemental Biologic License Application
(sBLA) in recurrent pericarditis to the FDA this year. Upon
receipt of FDA approval for rilonacept in recurrent pericarditis,
Kiniksa will assume the sales and distribution of rilonacept for
the approved indications in the United States and evenly
split profits on sales with Regeneron.
About KiniksaKiniksa 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 clinical-stage 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 that are implicated
across a spectrum of diseases. For more information, please
visit www.kiniksa.com.
About Recurrent Pericarditis Recurrent
pericarditis is a painful and debilitating autoinflammatory
cardiovascular disease that typically presents with chest pain and
is often associated with changes in electrical conduction and
sometimes buildup of fluid around the heart, called pericardial
effusion. Patients with pericarditis are deemed recurrent if they
have an additional episode after a symptom-free period of 4-6 weeks
and chronic if symptoms from any one episode last longer than three
months. Recurrent pericarditis symptoms impair qualify of life,
limit physical activities, and lead to frequent emergency
department visits and hospitalizations. Claims analysis, cross
validated with published research estimates, supports a prevalent
population of approximately 40,000 patients in the U.S. seeking and
receiving medical treatment. There are currently no FDA-approved
treatments for recurrent pericarditis.
About RilonaceptRilonacept is a weekly,
subcutaneously-injected, recombinant fusion protein that blocks
IL-1α and IL-1β signaling. Rilonacept was discovered and developed
by Regeneron and is approved by the FDA under the brand name
ARCALYST® for the treatment of CAPS, specifically Familial Cold
Autoinflammatory Syndrome and Muckle-Wells Syndrome. Rilonacept for
the treatment of deficiency of the interleukin-1 receptor
antagonist (DIRA) is currently pending FDA approval following the
submission of an sBLA in June 2020. Rilonacept in recurrent
pericarditis is an investigational drug. The FDA granted
Breakthrough Therapy designation to rilonacept for recurrent
pericarditis in 2019 and Orphan Drug designation to rilonacept for
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
infections.
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.
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: plans and
timing of submitting a supplemental BLA to the FDA in recurrent
pericarditis; our beliefs about the potential to bring rilonacept
as a potential treatment option for patients with recurrent
pericarditis; and our beliefs about the mechanisms of action of our
product candidates and potential impact of their approach.
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: 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
changes between final data and any preliminary, interim, top-line
or other data we announce; impact of additional data from us or
other companies; our reliance on third parties as the sole source
of supply of the drug substance and drug products used in our
product candidates; substantial existing or new competition;
potential 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 from those indicated by the
forward-looking statements made in this press release. Any such
forward-looking statements represent management’s plans, estimates,
or expectations as of the date of this press release. While we may
elect to update such forward-looking statements at some point in
the future, we disclaim any obligation to do so, even if subsequent
events cause our views to change. 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
Pharmaceuticals, Inc. and Yescarta® is a registered trademark
of Gilead Sciences, Inc., or its related companies.
Every Second Counts!™
Kiniksa Investor and Media ContactMark
Ragosa(781) 430-8289mragosa@kiniksa.com
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