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 data from the global Phase 2 clinical trial of
mavrilimumab in giant cell arteritis (GCA) were presented at the
late-breaking abstracts session during the American College of
Rheumatology (ACR) Convergence 2020. Mavrilimumab is an
investigational fully-human monoclonal antibody that targets
granulocyte macrophage colony stimulating factor receptor alpha
(GM-CSFRα). Both the primary and secondary efficacy endpoints
achieved statistical significance, and there was a consistent trend
of efficacy across the new onset and relapsing/refractory cohorts.
“There is a real need for novel therapies for
patients with giant cell arteritis,” said Dr. Maria
Cid, Hospital Clínic, University of Barcelona, IDIBAPS.
“My fellow co-principal investigator, Dr. Sebastian Unizony, and I
presented data which show that mavrilimumab significantly reduced
risk of flare and increased sustained remission compared to
placebo. This is an encouraging potential therapeutic advancement
for these patients, particularly for those with relapsed/refractory
disease, as many are not able to achieve sustained remission on
current standard of care. I look forward to further investigation
of mavrilimumab in subsequent clinical trials.”
Dr. Maria Cid1, a co-principal investigator for the
global Phase 2 trial, delivered a virtual presentation entitled
Mavrilimumab (Anti GM-CSF Receptor α Monoclonal Antibody) Reduces
Risk of Flare and Increases Sustained Remission in a Phase 2 Trial
of Patients with Giant Cell Arteritis at the late-breaking
abstracts session (L06 - L11) on Monday, November 9, 2020 at 11:30
a.m. Eastern Time. Dr. Sebastian Unizony2 is a co-principal
investigator.
The Phase 2 trial randomized 70 patients 3:2 to
mavrilimumab 150 mg (n=42) or placebo (n=28) biweekly injected
subcutaneously, co-administered with a protocol-defined 26-week
oral corticosteroid taper. Patients were stratified by new onset
(n=35) or relapsing/refractory (n=35) disease.
Both the primary efficacy endpoint of time-to-first
adjudicated GCA flare by Week 26 in all treated patients (Hazard
Ratio = 0.38, p=0.0263) and the secondary efficacy endpoint of
sustained remission at Week 26 in all treated patients (33.3
percentage point increase; p=0.0038) were statistically
significant. Additionally, while the trial was not powered for
individual disease cohorts, there was a consistent trend of
efficacy across the new onset and relapsing/refractory cohorts.
Mavrilimumab was well-tolerated; there were no
drug-related serious adverse events, and the rates of drug-related
treatment-emergent adverse events between mavrilimumab recipients
and placebo recipients were similar.
The 12-week washout safety follow-up period is
ongoing, and additional analyses of this Phase 2 trial are planned.
Next steps for the development program in GCA will be further
informed by anticipated discussions with the U.S. Food and
Drug Administration (FDA).
The FDA recently granted Orphan Drug designation to
mavrilimumab for the treatment of GCA.
Kiniksa is also evaluating mavrilimumab in severe
COVID-19 pneumonia and hyperinflammation and is enrolling the Phase
2 portion of a global, randomized, double-blind, placebo-controlled
adaptive design Phase 2/3 clinical trial. Additionally, data are
expected from a randomized, double-blind, placebo-controlled
investigator-initiated study in the U.S. in the fourth
quarter of 2020.
1 Hospital Clínic, University
of Barcelona, Institut d’Investigacions
Biomèdiques August Pi i Sunyer (IDIBAPS); 2 Massachusetts
General Hospital, Harvard University
About the Global Phase 2 Clinical Trial of
Mavrilimumab in GCAThe randomized, double-blind,
placebo-controlled, global Phase 2 clinical trial of mavrilimumab
in GCA consists of a 6-week screening period, a 26-week
double-blind placebo-controlled treatment period, and a 12-week
washout safety follow-up period. Patients age 50 to 85 years with
active GCA, confirmed by temporal artery biopsy and/or imaging,
with erythrocyte sedimentation rate (ESR) ≥ 30 mm/hour or
C-reactive protein (CRP) ≥ 1 mg/dL, and symptoms of GCA within 6
weeks from randomization, were included. All patients were required
to have achieved corticosteroid-induced remission (resolution of
symptoms, ESR < 20 mm/hour, CRP < 1 mg/dL) prior to
randomization.
About Giant Cell ArteritisGiant
cell arteritis is a rare chronic inflammatory disease of
medium-to-large arteries. Cranial giant cell arteritis typically
presents with headache and jaw claudication as well as
constitutional symptoms of fever and fatigue. Acute events can
include permanent vision loss from diminished blood flow to the
eye. The large vessel form of giant cell arteritis affects the
branches of the aorta supplying the trunk and limbs. There is
currently one FDA-approved treatment for giant cell arteritis as an
adjunct to a corticosteroid taper.
About MavrilimumabMavrilimumab is
an investigational fully-human monoclonal antibody that targets
GM-CSFRα. 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.
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 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: the need for
novel therapies for patients with giant cell arteritis (“GCA”);
mavrilimumab’s potential to offer a treatment option for patients
with GCA, particularly patients with relapsing/refractory disease;
the unmet need for patients with GCA; continued analyses of the
on-going washout period Phase 2 trial data; next steps for the
development program in GCA being further informed by anticipated
discussions with the FDA; the timing of data from our clinical
trials or investigator initiated studies; and the potential for 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 impact of additional data from us,
investigator-initiated studies or other companies; the potential
for undesirable side effects to be caused by mavrilimumab; the
potential inability to replicate in later studies or clinical
trials positive results from earlier studies or clinical trials;
the impact of discussions with the FDA on our development program
in GCA; our reliance on third parties to manufacture our product
candidates and conduct our clinical trials and/or perform certain
regulatory activities for our product candidates; drug substance
and/or drug product shortages, including in connection with our
engagement of a manufacturing organization to produce mavrilimumab
beyond our current inventory; the potential 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 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 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) 430-8289mragosa@kiniksa.com
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