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 announced that the U.S. Food and Drug Administration
(FDA) granted Breakthrough Therapy designation to vixarelimab
for the treatment of pruritus associated with prurigo nodularis, a
chronic inflammatory skin condition characterized by severely
pruritic skin nodules. Vixarelimab is a fully-human monoclonal
antibody that targets oncostatin M receptor beta (OSMRβ).
Kiniksa’s Breakthrough Therapy application was based on data
from the Phase 2a clinical trial of vixarelimab in prurigo
nodularis. The Phase 2a trial met its primary efficacy endpoint:
there was a statistically significant reduction in weekly-average
Worst-Itch Numeric Rating Scale (WI-NRS) from baseline at Week 8 in
vixarelimab recipients compared to placebo recipients.
Additionally, the majority of vixarelimab recipients showed a
clinically meaningful greater-than-or-equal-to 4-point
weekly-average WI-NRS reduction at Week 8, and a statistically
significant percentage of vixarelimab recipients achieved a prurigo
nodularis-investigator’s global assessment (PN-IGA) score of 0/1 at
Week 8 compared to placebo recipients.
“The FDA granting Breakthrough Therapy designation to
vixarelimab for the treatment of pruritus associated with prurigo
nodularis is an important step forward for patients,” said Sanj K.
Patel, Chief Executive Officer and Chairman of the Board of
Kiniksa. “The Phase 2a study of vixarelimab in prurigo nodularis
demonstrated encouraging results in both pruritus and nodule
response. We believe vixarelimab has the potential to positively
impact the lives of those suffering from prurigo nodularis, a
devastating disease for which there are no FDA-approved
therapies.”
Kiniksa expects to initiate a Phase 2b clinical trial of
vixarelimab in prurigo nodularis, evaluating a range of
once-monthly dose regimens, by the end of the year.
About Breakthrough Therapy
DesignationThe FDA defines Breakthrough Therapy
designation as a process designed to expedite the development and
review of drug candidates that are intended to treat a serious
condition, and preliminary clinical evidence indicates that the
drug candidate may demonstrate substantial improvement over
available therapies on a clinically significant endpoint.
About
Vixarelimab Phase
2a Trial in
Prurigo Nodularis The Phase 2a trial
was a randomized, double-blind, placebo-controlled study designed
to investigate the efficacy, safety, tolerability, and
pharmacokinetics of vixarelimab in reducing pruritus in
subjects with prurigo nodularis. The trial enrolled patients with
moderate-to-severe prurigo nodularis experiencing
moderate-to-severe pruritus (WI-NRS ≥ 7 at the screening visit and
a mean weekly WI-NRS of ≥ 5 for each of the two consecutive weeks
immediately prior to randomization). Patients were required to stop
antihistamines and topical treatments, including corticosteroids,
for at least two weeks prior to dosing. Prurigo nodularis
treatments, other than study drug, were not allowed except for
rescue. For more information, refer
to ClinicalTrials.gov Identifier: NCT03816891.
About VixarelimabVixarelimab
is an investigational fully-human monoclonal antibody that targets
OSMRβ, 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.
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 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 www.kiniksa.com.
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
beliefs about research, pre-clinical and clinical trial data
demonstrating encouraging results; our beliefs about the potential
to positively impact the lives of patients with prurigo nodularis
and the importance for such patients of vixarelimab having been
granted Breakthrough Therapy designation for the treatment of
prurigo nodularis; planned clinical trials and timing thereof,
including a potential dose-ranging Phase 2b clinical trial of
vixarelimab in prurigo nodularis; 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: 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 November 5, 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.
Every Second Counts!™
Kiniksa Investor and Media ContactMark
Ragosa(781) 430-8289mragosa@kiniksa.com
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