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 presentation of data from the Phase 2a clinical
trial of vixarelimab in prurigo nodularis at the European Academy
of Dermatology and Venereology (EADV) Virtual Congress. Kiniksa
previously reported positive results from the trial in April 2020.
Vixarelimab is a fully-human monoclonal antibody that targets
oncostatin M receptor beta (OSMRβ).
Dr. Howard Sofen, MD, Associate Clinical Professor of
Dermatology at the David Geffen UCLA School of Medicine delivered a
virtual presentation entitled, Vixarelimab Reduced Pruritus,
Improved Nodules, and was Well-Tolerated in Patients with Prurigo
Nodularis in a Phase 2a, Randomized, Double-Blind,
Placebo-Controlled Study. The presentation is available through the
Science section of Kiniksa’s website.
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, 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, and the majority of vixarelimab recipients showed a
clinically meaningful greater-than-or-equal-to 4-point
weekly-average WI-NRS reduction at Week 8.
“Prurigo nodularis is a debilitating chronic inflammatory skin
condition characterized by severely pruritic skin nodules. A
significant unmet need remains,” said Dr. Howard Sofen, MD, David
Geffen UCLA School of Medicine. “In the Phase 2a study, vixarelimab
demonstrated significant reductions in pruritus in this disease for
which there are currently no FDA-approved therapies. Even more
encouraging was seeing significant nodule resolution at Week 8. I
look forward to further investigation of vixarelimab in subsequent
trials.”
The Phase 2a trial enrolled 49 patients with moderate-to-severe
prurigo nodularis (42.9% with a PN-IGA score of 4, 55.1% with a
score of 3, and 2.0% with a score of 2) experiencing
moderate-to-severe pruritus (mean WI-NRS score of 8.3). Patients
were randomized 1:1 to receive a loading dose of vixarelimab 720 mg
(n=23) or placebo (n=26) subcutaneous (SC) followed by vixarelimab
360 mg or placebo SC weekly. The primary efficacy endpoint was
percent change versus baseline in weekly-average WI-NRS at Week 8
(using the last observation carried forward analysis).
- Least squares-mean change from baseline in weekly-average
WI-NRS at Week 8 was -50.6% in vixarelimab recipients compared to
-29.4% in placebo recipients (mean difference 21.1%; p=0.035).
- Median change from baseline in weekly-average WI-NRS at Week 8
was -69.8% in vixarelimab recipients compared to -36.1% in placebo
recipients.
- 30.4% of vixarelimab recipients achieved a PN-IGA score of 0/1
at Week 8 compared to 7.7% of placebo recipients (p=0.032).
- 52.2% of vixarelimab recipients
demonstrated a ≥ 4-point reduction in weekly-average WI-NRS at Week
8 compared to 30.8% of placebo recipients (p=0.109).
In the Phase 2a trial, vixarelimab was well-tolerated by all
subjects, and no dose-limiting adverse experiences were observed.
There were no serious adverse events or atopic dermatitis
flares.
Kiniksa expects to initiate a dose-ranging Phase 2b clinical
trial of vixarelimab in prurigo nodularis in the fourth quarter of
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.
About Vixarelimab Vixarelimab
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.
About Vixarelimab
Phase 2a Trial in
Prurigo NodularisThe 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.
Forward-Looking StatementsThe information
contained in 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: timing of planned clinical
trials, including timing for Kiniksa to initiate a Phase 2b
dose-ranging trial of vixarelimab in prurigo nodularis in the
fourth quarter of 2020; the potential impact and differentiation of
the OSMRβ mechanism; the potential for vixarelimab to positively
impact the lives of patients with prurigo nodularis; and the
potential for all of our clinical stage product candidates to offer
differentiation.
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: the potential for changes between final or a broader set
of data and any “top-line,” interim and preliminary data we
announce; impact of additional data from us or other companies; the
potential inability to replicate in later clinical trials positive
results from our Phase 2a clinical trial with vixarelimab in
patients with prurigo nodularis; the potential for undesirable side
effects to be caused by vixarelimab; our reliance on third parties
to conduct clinical trials for vixarelimab; the impact of the
COVID-19 pandemic and measures taken in response to the pandemic;
changes in our operating plan and funding requirements; existing or
new competition; and our ability to attract and retain qualified
personnel.
These and other important factors discussed under the caption
“Risk Factors” in our Annual Report on Form 10-K filed with the
Securities and Exchange Commission (“SEC”) on August 4, 2020 and
our other reports subsequently filed with or furnished to 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
estimates 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)
430-8779mragosa@kiniksa.com
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