—Data Presented at the CHEST 2024 Annual
Meeting—
BRIDGEWATER, N.J., Oct. 8, 2024
/PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first
global biopharmaceutical company striving to deliver first- and
best-in-class therapies to transform the lives of patients facing
serious diseases, today presented positive late-breaking subgroup
data from the Phase 3 ASPEN study, a global, randomized,
double-blind, placebo-controlled Phase 3 study to assess the
efficacy, safety, and tolerability of brensocatib in patients with
non-cystic fibrosis bronchiectasis. Posters with the details from
these subgroup analyses can be found HERE. These data were
presented at the CHEST 2024 Annual Meeting, held October 6-9 in Boston, along with several other presentations
from across Insmed's respiratory portfolio.
"The positive results from the landmark Phase 3 ASPEN study have
generated tremendous excitement among physicians and patients
alike, providing hope for a much-needed approved treatment for
bronchiectasis. Given the heterogeneity of this disease, it is
striking that these new sub-analyses show a consistent positive
impact on the rate of exacerbations across the majority of
prespecified subgroups," said lead study investigator James Chalmers, MBChB, Ph.D., Professor and
Consultant Respiratory Physician at the School of Medicine,
University of Dundee, UK. "It is
particularly exciting to see that, consistent with the overall
trial analysis, brensocatib 25 mg was able to slow lung function
decline as measured by FEV1 for all prespecified subgroups, further
underscoring the potential impact this investigational treatment
candidate may have on a diverse range of patients if approved."
Consistent with positive results for the overall ASPEN population, the annualized rate of
pulmonary exacerbations favored brensocatib at both the 10 mg and
25 mg doses over placebo for almost all subgroups. In a
separate analysis, least squares mean difference for brensocatib 25
mg demonstrated a reduced decline in post-bronchodilator FEV1 at
Week 52 versus placebo for all prespecified subgroups. Results for
patients treated with brensocatib 10 mg among subgroups were
aligned with the overall trial population results.
Brensocatib was well-tolerated in the study. Treatment-emergent
adverse events (TEAEs) occurring in at least 5.0% of patients
treated with either dose of brensocatib and more frequently than in
placebo were COVID-19 (15.8%, 20.9%, 15.8%), nasopharyngitis (7.7%,
6.3%, 7.6%), cough (7.0%, 6.1%, 6.4%), and headache (6.7%, 8.5%,
and 6.9%) for brensocatib 10 mg, brensocatib 25 mg, and placebo,
respectively.
"We are incredibly excited to present subgroup findings from the
ASPEN study at CHEST 2024,
building on the positive results we have already shared with the
bronchiectasis community," said Martina
Flammer, M.D., MBA, Chief Medical Officer of Insmed. "The
consistency of efficacy observed across most subgroups,
particularly at the higher dose, further supports our belief that
brensocatib has the potential to transform the treatment landscape
for patients with bronchiectasis. We eagerly look forward to filing
a new drug application for brensocatib in the U.S., followed by
Europe and Japan, in hopes of delivering the first
approved therapy for patients affected by this serious and
difficult-to-treat disease."
Insmed plans to file a New Drug Application with the U.S. Food
and Drug Administration for brensocatib in patients with
bronchiectasis in the fourth quarter of 2024. Pending regulatory
approvals, Insmed anticipates a U.S. launch for brensocatib in
mid-2025 followed by launches in Europe and Japan in the first half of 2026. If approved,
brensocatib would be the first approved treatment for patients with
bronchiectasis as well as the first approved dipeptidyl peptidase 1
(DPP1) inhibitor—a new mechanism of action with the potential to
address a range of neutrophil-mediated diseases.
About ASPEN
As part
of the ASPEN study's conduct, more than 460 trial sites
were engaged in nearly 40 countries. After excluding sites that did
not enroll any patients and all sites in Ukraine, the total
number of active sites in ASPEN was 391 sites in 35
countries. Adult patients (ages 18 to 85 years) were randomized
1:1:1 and adolescent patients (ages 12 to <18 years) were
randomized 2:2:1 for treatment with brensocatib 10 mg, brensocatib
25 mg, or placebo once daily for 52 weeks, followed by 4 weeks off
treatment. The primary efficacy analysis included data from 1,680
adult patients and 41 adolescent patients.
About Brensocatib
Brensocatib is a small molecule,
oral, reversible inhibitor DPP1 being developed by Insmed for the
treatment of patients with bronchiectasis, CRSsNP, and other
neutrophil-mediated diseases. DPP1 is an enzyme responsible for
activating neutrophil serine proteases (NSPs), such as neutrophil
elastase, in neutrophils when they are formed in the bone marrow.
Neutrophils are the most common type of white blood cell and play
an essential role in pathogen destruction and inflammatory
mediation. In chronic inflammatory lung diseases, neutrophils
accumulate in the airways and result in excessive active NSPs that
cause lung destruction and inflammation. Brensocatib may decrease
the damaging effects of inflammatory diseases such as
bronchiectasis by inhibiting DPP1 and its activation of NSPs.
Brensocatib is an investigational drug product that has not been
approved for any indication in any jurisdiction.
About Insmed
Insmed Incorporated is a people-first
global biopharmaceutical company striving to deliver first- and
best-in-class therapies to transform the lives of patients facing
serious diseases. The Company is advancing a diverse portfolio of
approved and mid- to late-stage investigational medicines as well
as cutting-edge drug discovery focused on serving patient
communities where the need is greatest. Insmed's most advanced
programs are in pulmonary and inflammatory conditions, including a
therapy approved in the United
States, Europe, and
Japan to treat a chronic,
debilitating lung disease. The Company's early-stage research
programs encompass a wide range of technologies and modalities,
including gene therapy, AI-driven protein engineering, protein
manufacturing, RNA end-joining, and synthetic rescue.
Headquartered in Bridgewater, New
Jersey, Insmed has offices and research locations throughout
the United States, Europe, and Japan. Insmed is proud to be recognized as one
of the best employers in the biopharmaceutical industry, including
spending three consecutive years as the No. 1 Science Top
Employer. Visit www.Insmed.com to learn more.
Forward-looking Statements
This press release contains
forward-looking statements that involve substantial risks and
uncertainties. "Forward-looking statements," as that term is
defined in the Private Securities Litigation Reform Act of 1995,
are statements that are not historical facts and involve a number
of risks and uncertainties. Words herein such as "may," "will,"
"should," "could," "would," "expects," "plans," "anticipates,"
"believes," "estimates," "projects," "predicts," "intends,"
"potential," "continues," and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) may identify forward-looking statements.
The forward-looking statements in this press release are based
upon the Company's current expectations and beliefs, and involve
known and unknown risks, uncertainties and other factors, which may
cause the Company's actual results, performance and achievements
and the timing of certain events to differ materially from the
results, performance, achievements or timings discussed, projected,
anticipated or indicated in any forward-looking statements. Such
risks, uncertainties and other factors include, among others, the
following: the risk that the full data set from the ASPEN study or data generated in further
clinical trials of brensocatib will not be consistent with the
topline results of the ASPEN study
or any additional results of the ASPEN study; failure to obtain, or delays in
obtaining, regulatory approvals for brensocatib in the U.S.,
Europe or Japan; failure to successfully commercialize
brensocatib, if approved by applicable regulatory authorities, in
the U.S., Europe or Japan, or to maintain U.S., European or
Japanese approval for brensocatib once approved; uncertainties in
the degree of market acceptance of brensocatib by physicians,
patients, third-party payors and others in the healthcare
community; inaccuracies in the Company's estimates of the size of
the potential markets for brensocatib or in data the Company has
used to identify physicians; expected rates of patient uptake,
duration of expected treatment, or expected patient adherence or
discontinuation rates; inability of the Company, Esteve
Pharmaceuticals, S.A., Thermo Fisher Scientific, Inc. or the
Company's other third-party manufacturers to comply with regulatory
requirements related to brensocatib; the Company's inability to
obtain adequate reimbursement from government or third-party payors
for brensocatib or acceptable prices for brensocatib; development
of unexpected safety or efficacy concerns related to brensocatib;
failure to obtain regulatory approval for potential future
brensocatib indications; restrictions or other obligations imposed
on us by agreements related to brensocatib, including our license
agreement with AstraZeneca AB, and failure to comply with our
obligations under such agreements; failure to successfully conduct
future clinical trials for brensocatib, including due to the
Company's potential inability to enroll or retain sufficient
patients to conduct and complete the trials or generate data
necessary for regulatory approval, among other things; risks that
the Company's clinical studies will be delayed or that serious side
effects will be identified during drug development; failure of
third parties on which the Company is dependent to manufacture
sufficient quantities of brensocatib for commercial or clinical
needs, to conduct the Company's clinical trials, or to comply with
the Company's agreements or laws and regulations that impact the
Company's business or agreements with the Company; the strength and
enforceability of the Company's intellectual property rights or the
rights of third parties; the cost and potential reputational damage
resulting from litigation to which the Company may become a party,
including product liability claims; changes in laws and regulations
applicable to the Company's business and failure to comply with
such laws and regulations; business or economic disruptions due to
catastrophes or other events, including natural disasters or public
health crises; and inability to repay the Company's existing
indebtedness and uncertainties with respect to the Company's need
and ability to access future capital.
The Company may not actually achieve the results, plans,
intentions or expectations indicated by the Company's
forward-looking statements because, by their nature,
forward-looking statements involve risks and uncertainties because
they relate to events and depend on circumstances that may or may
not occur in the future. For additional information about the risks
and uncertainties that may affect the Company's business, please
see the factors discussed in Item 1A, "Risk Factors," in the
Company's Annual Report on Form 10-K for the year ended
December 31, 2023 and any subsequent
Company filings with the Securities and Exchange Commission
(SEC).
The Company cautions readers not to place undue reliance on any
such forward-looking statements, which speak only as of the date of
this press release. The Company disclaims any obligation, except as
specifically required by law and the rules of the SEC, to publicly
update or revise any such statements to reflect any change in
expectations or in events, conditions or circumstances on which any
such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements.
Contact:
Investors:
Bryan Dunn
Executive Director, Investor Relations
Insmed
(646) 812-4030
bryan.dunn@insmed.com
Media:
Mandy Fahey
Vice President, Corporate Communications
Insmed
(732) 718-3621
amanda.fahey@insmed.com
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