MONMOUTH JUNCTION, N.J.,
May 23, 2012 /PRNewswire/
-- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical
company, today announced that it has begun screening patients for
its U.S. phase 2 clinical trial, Treatment with
ARIKACE to Realize Greater Efficacy
Trial (TARGET-NTM), of ARIKACE® (liposomal amikacin for
inhalation) in patients with non-tuberculous mycobacterial (NTM)
lung disease.
There have been very few clinical trials to support current NTM
treatment recommendations, and no new drugs have been assessed in
randomized trials for NTM lung disease in many years.
Additionally, NTM remains a significantly under-diagnosed
disease. TARGET-NTM represents an opportunity to make
significant advancement in the awareness and treatment of this
debilitating chronic illness, according to Kenneth N. Olivier, M.D., M.P.H., Principal
Investigator of the study and staff pulmonologist in the Laboratory
of Clinical Infectious Diseases at the National Institute of
Allergy and Infectious Diseases, part of the National Institutes of
Health.
"Current treatment for NTM lung disease requires lengthy
multi-drug regimens that can be poorly tolerated and have limited
efficacy, especially in patients with severe disease or in those
who have failed prior treatment attempts," said David E. Griffith, M.D., lead author of the
American Thoracic Society's and the Infectious Disease Society of
America's diagnosis and treatment guidelines for NTM, and Professor
of Medicine at the University of Texas
Health Science Center at Tyler. "If effective, ARIKACE has the
potential to significantly impact the current NTM treatment
paradigm." Dr. Griffith, along with Richard J Wallace, M.D.,
Professor of Medicine and Microbiology, also at the University of Texas Health Science Center at Tyler,
are Co-Principal Investigators for the study.
NTM Increasingly Prevalent
According to a recent company sponsored patient chart study
conducted by Clarity Pharma Research, approximately 50,000 patients
suffering from NTM lung disease visited physician offices in the
U.S. during 2011. More than half of these patients were
treated with antibiotics for NTM. This reflects a much
larger patient population than previous Insmed estimates.
Patients in the trial will have lung infections with
Mycobacterium avium complex (MAC) or Mycobacterium
abscessus, which account for approximately 75 percent to over
85 percent of all patients with NTM lung disease in the
U.S.
Treatment with ARIKACE to
Realize Greater Efficacy
Trial (TARGET-NTM)
- Randomized, placebo-controlled study of ARIKACE in
approximately 100 adult patients with recalcitrant NTM lung
disease.
- Patients will continue with their antibiotic regimen, and
receive additionally, either ARIKACE 560 mg or placebo, delivered
once daily via an optimized, investigational eFlow® Nebulizer
System (PARI Pharma GmbH).
- Primary efficacy endpoint will be change in mycobacterial
density from baseline to the end of 84 days of treatment, which is
the end of the randomized portion of the trial.
- At the conclusion of the randomized portion of the study,
eligible patients may receive ARIKACE 560 mg once daily for an
additional 84 days in an open-label design. Open-label means the
patient will know they are receiving ARIKACE.
Patient dosing is expected to begin in mid-2012, with top-line
results for the randomized portion of the trial projected in the
fourth quarter of 2013. The clinical trial design has been
agreed upon by Insmed and the U.S. Food and Drug
Administration. For more information on the clinical trial,
visit www.clinicaltrials.gov.
Also, as recently announced, Insmed has begun dosing patients
in CLEAR-108, a European and Canadian registrational phase 3
clinical study of ARIKACE in CF patients with Pseudomonas
aeruginosa lung infections, and is proceeding with CLEAR-110, a
follow-on multi-cycle open-label study intended primarily to
measure safety and tolerability for patients who complete
CLEAR-108.
About Insmed
Insmed Incorporated is a biopharmaceutical company focused on
the development of innovative inhaled pharmaceuticals for the
site-specific treatment of serious lung diseases. Insmed's
primary focus is on the development of inhaled antibiotic therapy
delivered via proprietary advanced liposomal pulmonary technology
in areas of high unmet need. For more information, please
visit http://www.insmed.com.
About eFlow® Technology and PARI Pharma
ARIKACE is delivered by an investigational eFlow® Nebulizer
System developed by PARI Pharma and optimized specifically for
ARIKACE. The optimized device uses eFlow Technology to enable
highly efficient aerosolization of medication including liposomal
formulations via a vibrating, perforated membrane that includes
thousands of laser drilled holes. Compared to other nebulization
technologies, eFlow Technology produces aerosols with a very high
density of active drug, a precisely defined droplet size, and a
high proportion of respirable droplets delivered in the shortest
possible period of time. eFlow Technology is not an ultrasonic
nebulizer technology, and it is not a general purpose electronic
aerosol generator nebulizer technology. Combined with its quiet
mode of operation, small size, light weight, and battery use, eFlow
Technology reduces the burden of taking daily, inhaled treatments.
PARI Pharma focuses on the development of aerosol delivery devices
and inhalation drug development to advance aerosol therapies where
drug and device can be optimized together. Online at
www.paripharma.com.
Forward-Looking Statements
This release contains forward-looking statements which are made
pursuant to provisions of Section 21E of the Securities Exchange
Act of 1934. Investors are cautioned that such statements in this
release, including statements relating to our financial position,
results of operations, the status and the results of pre-clinical
studies and clinical trials and preclinical and clinical data
described herein, the timing of and costs associated with
pre-clinical studies and clinical trials, the development of our
products, our estimates of the size of the potential markets for
our product candidates, and the business strategies, plans and
objectives of management, constitute forward-looking statements
which involve risks and uncertainties that could cause actual
results to differ materially from those anticipated by the
forward-looking statements. Our results may be affected by
such factors as the receipt and timing of FDA and other regulatory
reviews and approvals, if at all, competitive developments
affecting our product development, delays in product development or
clinical trials, and patent disputes involving currently developing
products. The risks and uncertainties include, without
limitation, we may experience unexpected regulatory actions, delays
or requests, our future clinical trials may not be successful, we
may be unsuccessful in developing our product candidates or
receiving necessary regulatory approvals, we may experience delays
in our product development or clinical trials, our product
candidates may not prove to be commercially successful, our
expenses may be higher than anticipated and other risks and
challenges detailed in our filings with the U.S. Securities and
Exchange Commission, including our Annual Report on Form 10-K for
the year ended December 31, 2011 and
our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2012. Investors are
cautioned not to place undue reliance on any forward-looking
statements which speak only as of the date of this release.
We undertake no obligation to publicly release the results of
any revisions to these forward-looking statements that may be made
to reflect events or circumstances that occur after the date of
this release or to reflect the occurrence of unanticipated
events.
Investor Relations Contact:
Brian Ritchie – FTI
Consulting
212-850-5683
brian.ritchie@fticonsulting.com
Media Contact:
Irma Gomez-Dib – FTI Consulting
212-850-5761
irma.gomez-dib@fticonsulting.com
SOURCE Insmed Incorporated