Kiniksa Commences Dosing of Vixarelimab Phase 2b Clinical Trial in Prurigo Nodularis
December 15 2020 - 8:00AM
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 the commencement of dosing in the Phase 2b clinical
trial of vixarelimab in 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). The U.S. Food and Drug
Administration (FDA) granted Breakthrough Therapy designation to
vixarelimab for the treatment of pruritus associated with prurigo
nodularis in 2020.
“We are pleased to announce the commencement of dosing in the
Phase 2b trial of vixarelimab in patients with prurigo nodularis.
The study builds upon learnings from our prior preclinical and
clinical work in the disease and will evaluate vixarelimab across a
range of once-monthly dose regimens,” said Sanj K. Patel, Chief
Executive Officer and Chairman of the Board of Kiniksa. “By
targeting the OSMRβ receptor, we believe vixarelimab has the
potential to make a meaningful impact on the lives of patients
suffering with prurigo nodularis by addressing both the pruritus
and the skin nodules associated with this devastating disease.”
The Phase 2b trial is a randomized, double-blind,
placebo-controlled study designed to investigate the efficacy,
safety, and pharmacokinetics of vixarelimab in patients
with prurigo nodularis. The trial is expected to enroll
approximately 180 patients experiencing moderate-to-severe
pruritus. Patients will be randomized 1:1:1:1 to receive
vixarelimab 540 mg, 360 mg, 120 mg, or placebo as a once-monthly
subcutaneous injection. The primary efficacy endpoint is the
percent change from baseline in the weekly-average Worst-Itch
Numeric Rating Scale (WI-NRS) at Week 16. Key secondary endpoints
include the proportion of patients achieving
greater-than-or-equal-to 4-point weekly-average WI-NRS reduction at
Week 16 and the proportion of patients achieving a 0/1 score
(clear/almost clear) on the prurigo nodularis-investigator’s global
assessment (PN-IGA) at Week 16.
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, as
there was a statistically significant reduction in the
weekly-average 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 PN-IGA score of 0/1 at Week 8 compared to
placebo recipients. Data from the Phase 2a trial were recently
presented at the European Academy of Dermatology and Venereology
Virtual Congress.
About Vixarelimab Phase
2b Trial in Prurigo Nodularis The Phase 2b
trial is a randomized, double-blind, placebo-controlled study
designed to investigate the efficacy, safety, and pharmacokinetics
of vixarelimab in reducing pruritus in subjects with
prurigo nodularis. The trial is enrolling 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 ≥ 7 for each of the two consecutive weeks
immediately prior to randomization). Patients are required to stop
antihistamines and topical treatments, including corticosteroids,
for at least two weeks prior to dosing. Prurigo nodularis
treatments, other than study drug, are not allowed except for
rescue.
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 the potential to impact the lives of patients with
prurigo nodularis by addressing both the pruritus and inflammatory
skin nodules associated with the debilitating disease; expected
number of patients to be enrolled in the dose-ranging Phase 2b
clinical trial of vixarelimab in prurigo nodularis; our beliefs
about the mechanisms of action of our product candidates and
potential impact of their approach; and our beliefs about
vixarelimab being the only monoclonal antibody in development that
targets both pathways simultaneously.
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 dose-ranging Phase 2b clinical trial of vixarelimab in
prurigo nodularis; potential amendments to our clinical trial
protocols initiated by us or required by regulatory authorities;
delays or difficulty in completing our dose-ranging Phase 2b
clinical trial of vixarelimab in prurigo nodularis, including as a
result of the COVID-19 pandemic; potential undesirable side effects
caused by vixarelimab; our potential inability to demonstrate
safety and efficacy to the satisfaction of applicable regulatory
authorities or otherwise producing negative, inconclusive or
commercially uncompetitive results; 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 vixarelimab in subsequent clinical
trials conducted by us or third parties; 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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