BRIDGEWATER, N.J., May 20, 2020 /PRNewswire/ -- Insmed Incorporated
(Nasdaq:INSM), a global biopharmaceutical company on a mission to
transform the lives of patients with serious and rare diseases,
today announced that new data from the Phase 2 WILLOW study of
brensocatib (formerly known as INS1007) in non-cystic fibrosis
bronchiectasis (NCFBE) will be presented during a virtual clinical
trials session hosted by the American Thoracic Society (ATS) on
Wednesday, June 24, 2020, at
2:00 pm ET. Data will be presented by
lead study investigator James
Chalmers, MBChB, Ph.D., Professor and Consultant Respiratory
Physician at the School of Medicine, University of
Dundee, UK. Insmed will hold a
conference call following the oral session during which Professor
Chalmers will further discuss the WILLOW data and Insmed management
will provide a business assessment of brensocatib.
Virtual Clinical Trials Session Details
The virtual session, titled Phase 2 Randomized Controlled
Trial of DPP1 Inhibitor Brensocatib (INS1007) in Patients with
Bronchiectasis: The WILLOW Study, is part of the ATS session
Breaking News: Clinical Trial Results in Pulmonary
Medicine.
Conference Call Details
Insmed will host a conference call on Wednesday, June 24, 2020 at 4:00 pm ET. Shareholders and other interested
parties may participate in the conference call by dialing (888)
317-6003 (domestic) or (412) 317-6061 (international) and
referencing conference ID number 9628054. The call will also be
webcast live on the company's website at www.insmed.com.
A replay of the conference call will be accessible approximately
one hour after its completion through July 8, 2020, by
dialing (877) 344-7529 (domestic) or (412) 317-0088 (international)
and referencing replay access code 10144366. A webcast of
the call will also be archived for 90 days under the Investor
Relations section of the Company's website
at www.insmed.com.
About WILLOW
WILLOW was a randomized, double-blind, placebo-controlled,
parallel-group, multi-center, multi-national, Phase 2 study to
assess the efficacy, safety and tolerability, and pharmacokinetics
of brensocatib administered once daily for 24 weeks in patients
with non-cystic fibrosis bronchiectasis (NCFBE). WILLOW was
conducted at 116 sites and enrolled 256 adult patients diagnosed
with NCFBE who had at least two documented pulmonary exacerbations
in the 12 months prior to screening. Patients were randomized 1:1:1
to receive either 10 mg or 25 mg of brensocatib or matching
placebo. The primary efficacy endpoint was the time to first
pulmonary exacerbation over the 24-week treatment period in the
brensocatib arms compared to the placebo arm.
About Brensocatib (Formerly INS1007)
Brensocatib is a small molecule, oral, reversible inhibitor of
dipeptidyl peptidase I (DPP1) being developed by Insmed for the
treatment of patients with bronchiectasis. 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.
About Non-Cystic Fibrosis Bronchiectasis
Non-cystic fibrosis bronchiectasis (NCFBE) is a severe, chronic
pulmonary disorder in which the bronchi become permanently dilated
due to a cycle of infection, inflammation, and lung tissue damage.
The condition is marked by frequent pulmonary exacerbations
requiring antibiotic therapy and/or hospitalizations. Symptoms
include chronic cough, excessive sputum production, shortness of
breath, and repeated respiratory infections, which can worsen the
underlying condition. NCFBE affects approximately 340,000 to
520,000 patients in the U.S. Today, there are no approved therapies
specifically targeting NCFBE in the U.S., Europe,
or Japan for the treatment of patients with NCFBE.
About Insmed
Insmed Incorporated is a global biopharmaceutical company on a
mission to transform the lives of patients with serious and rare
diseases. Insmed's first commercial product, ARIKAYCE®
(amikacin liposome inhalation suspension), is the first and only
therapy approved in the United
States for the treatment of refractory Mycobacterium
avium complex (MAC) lung disease as part of a combination
antibacterial drug regimen for adult patients with limited or no
alternative treatment options. MAC lung disease is a chronic,
debilitating condition that can cause severe and permanent lung
damage. Insmed's earlier-stage clinical pipeline includes
brensocatib, a novel oral reversible inhibitor of dipeptidyl
peptidase 1 with therapeutic potential in non-cystic fibrosis
bronchiectasis and other inflammatory diseases, and treprostinil
palmitil, an inhaled formulation of a treprostinil prodrug that may
offer a differentiated product profile for rare pulmonary
disorders, including pulmonary arterial hypertension. For more
information, visit www.insmed.com.
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 timing 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 WILLOW study,
our six-month Phase 2 trial of brensocatib in patients with NCBFE
or data generated in further clinical trials of brensocatib will
not be consistent with the top-line results of the study; the risk
that brensocatib does not prove effective or safe for patients in
the STOP-COVID19 study; business or economic disruptions due to
catastrophes or other events, including natural disasters or public
health crises; impact of the novel coronavirus (COVID-19) pandemic
and efforts to reduce its spread on our business, employees,
including key personnel, patients, partners and suppliers; failure
to successfully commercialize or maintain U.S. approval for
ARIKAYCE, the Company's only approved product; uncertainties in the
degree of market acceptance of ARIKAYCE by physicians, patients,
third-party payors and others in the healthcare community; the
Company's inability to obtain full approval of ARIKAYCE from the
FDA, including the risk that the Company will not timely and
successfully complete the study to validate a PRO tool and complete
the confirmatory post-marketing study required for full approval of
ARIKAYCE; inability of the Company, PARI or the Company's other
third party manufacturers to comply with regulatory requirements
related to ARIKAYCE or the Lamira® Nebulizer System; the Company's
inability to obtain adequate reimbursement from government or
third-party payors for ARIKAYCE or acceptable prices for ARIKAYCE;
development of unexpected safety or efficacy concerns related to
ARIKAYCE or brensocatib; inaccuracies in the Company's estimates of
the size of the potential markets for ARIKAYCE or 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; the Company's inability to
create an effective direct sales and marketing infrastructure or to
partner with third parties that offer such an infrastructure for
distribution of ARIKAYCE; failure to obtain regulatory approval to
expand ARIKAYCE's indication to a broader patient population;
failure to successfully conduct future clinical trials for
ARIKAYCE, brensocatib and the Company's other product candidates,
including due to the Company's limited experience in conducting
preclinical development activities and clinical trials necessary
for regulatory approval and the Company's inability to enroll or
retain sufficient patients to conduct and complete the trials or
generate data necessary for regulatory approval; risks that the
Company's clinical studies will be delayed or that serious side
effects will be identified during drug development; failure to
obtain, or delays in obtaining, regulatory approvals for ARIKAYCE
outside the U.S. or for the Company's product candidates in the
U.S., Europe, Japan or other markets, including the
United Kingdom as a result of its
recent exit from the European Union; failure of third parties on
which the Company is dependent to manufacture sufficient quantities
of ARIKAYCE or the Company's product candidates for commercial or
clinical needs, to conduct the Company's clinical trials, or to
comply with laws and regulations that impact the Company's business
or agreements with the Company; the Company's inability to attract
and retain key personnel or to effectively manage the Company's
growth; the Company's inability to adapt to its highly competitive
and changing environment; the Company's inability to adequately
protect its intellectual property rights or prevent disclosure of
its trade secrets and other proprietary information and costs
associated with litigation or other proceedings related to such
matters; restrictions or other obligations imposed on the Company
by its agreements related to ARIKAYCE or the Company's product
candidates, including its license agreements with PARI and
AstraZeneca AB, and failure of the Company to comply with its
obligations under such agreements; the cost and potential
reputational damage resulting from litigation to which the Company
is or may become a party, including product liability claims; the
Company's limited experience operating internationally; changes in
laws and regulations applicable to the Company's business,
including any pricing reform, and failure to comply with such laws
and regulations; inability to repay the Company's existing
indebtedness and uncertainties with respect to the Company's
ability to access future capital; and delays in the execution of
plans to build out an additional FDA-approved third-party
manufacturing facility and unexpected expenses associated with
those plans.
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, 2019, our Quarterly Report on Form 10-Q for
the quarter ended March 31,
2020 and any subsequent Company filings with the 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:
Argot Partners
Laura Perry or Heather Savelle
(212) 600-1902
Insmed@argotpartners.com
Media:
Mandy Fahey
Senior Director, Corporate Communications
Insmed
(732) 718-3621
amanda.fahey@insmed.com
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SOURCE Insmed Incorporated