Aradigm Awarded NIH Grant to Investigate the Treatment of Pulmonary Non-Tuberculous Mycobacterial (PNTM) Infections with Linhaliq
HAYWARD, Calif.--(BUSINESS WIRE)--
The National Institute of Allergy and Infectious Diseases (NIAID) and
National Institutes of Health (NIH) awarded Aradigm Corporation
(NASDAQ:ARDM) a Small Business Initiative Research (SBIR) grant to
investigate the treatment of two pulmonary non-tuberculous mycobacteria
(PNTM) infections, Mycobacterium avium and Mycobacterium
abscessus, with Aradigm's inhaled liposomal ciprofloxacin products
Linhaliq™ and Lipoquin®. The Principal Investigator is Dr. James D.
Blanchard, Principal Scientist, Preclinical Development at Aradigm.
Professor Luiz Bermudez at Oregon State University, Corvallis, will lead
the laboratory research as a part of the consortium funded by this two
year grant of approximately $972,000.
According to a report from NIH based on an epidemiological study in U.S.
adults aged 65 years or older, PNTM infections are an important cause of
morbidity among older adults in the United States. From 1997 to 2007,
the annual prevalence significantly increased from 20 to 47 cases per
100,000 persons, or 8.2% per year. Forty-four percent of PNTM-affected
people in the study had bronchiectasis compared to 1% in the non-PNTM
cases, pointing to an important co-morbidity. PNTM infections are common
also in patients with other chronic lung conditions, such as cystic
fibrosis and emphysema.
The Phase II SBIR grant builds upon the encouraging results demonstrated
in the Phase I SBIR grant that found both Linhaliq and Lipoquin to have
significant efficacy against M. avium complex and M. abscessus
infection. The current standard of treatment of mycobacterial infections
is the simultaneous use of multiple antibiotics, and the Phase II grant
will focus on combination therapies. For M. avium complex
infection, the efficacy of Linhaliq and Lipoquin will be tested in
combination with clarithromycin, ethambutol, and amikacin using
macrophage and biofilm test systems as well as a mouse lung infection.
For M. abscessus infection, the efficacy of Linhaliq and Lipoquin
will be tested in combination with linezolid and imipenem. The emergence
of antibiotic resistance will be investigated.
"Pulmonary infections with non-tuberculous mycobacteria (NTM) have
become a serious growing public health problem in the U.S. and many
other countries as they can result in debilitating lung disease and are
costly to treat. We have shown that lung-delivered liposomal
ciprofloxacin is effective in in vitro and animal models of NTM
without causing the emergence of resistant NTM. Patients with NTM at
present typically have to use several antibiotics to avoid the emergence
of resistance. This NIH grant is important as it enables us to compare
the benefits of lung-delivered liposomal ciprofloxacin alone or in
combination with other antibiotics," said Prof. Bermudez.
"Bronchiectasis and chronic lung infections with Pseudomonas
aeruginosa and NTM are frequent co-morbidities. It is our goal to
deliver a much needed new treatment for these patients with severe lung
diseases," said Dr. Blanchard.
Linhaliq, formerly known as Pulmaquin®, is composed of a mixture of
liposome encapsulated and unencapsulated ciprofloxacin. Ciprofloxacin,
available in oral and intravenous formulations, is a widely prescribed
antibiotic. It is used often to treat acute lung infections because of
its broad-spectrum antibacterial activity against various bacteria, such
as Pseudomonas aeruginosa. Aradigm's once-a-day novel inhaled
formulations of ciprofloxacin are encapsulated in liposomes, allowing
for a sustained release of the drug within the lung and improving airway
tolerability. The formulations are to be used for chronic maintenance
therapy as they are expected to achieve higher antibiotic concentration
at the site of infection and relatively low systemic antibiotic
concentrations to minimize side-effects. Lipoquin is a liposomal
formulation of ciprofloxacin. Linhaliq is a dual release formulation
that is a mixture of Lipoquin with unencapsulated ciprofloxacin. Aradigm
completed two Phase 3 clinical trials with once daily inhaled Linhaliq
in patients with non-cystic fibrosis bronchiectasis (NCFBE) with chronic
lung infections with Pseudomonas aeruginosa and submitted a New
Drug Application to the U.S. Food & Drug Administration for this product
candidate in July 2017. Once daily inhaled Lipoquin was tested in Phase
1 and Phase 2 clinical trials in healthy subjects, cystic fibrosis
patients and non-cystic fibrosis bronchiectasis patients.
Aradigm is an emerging specialty pharmaceutical company focused on the
development and commercialization of drugs for the prevention and
treatment of severe respiratory diseases. Aradigm has completed Phase 3
development of Linhaliq (an investigational proprietary formulation of
ciprofloxacin for inhalation) for the treatment of NCFBE. Aradigm's
inhaled ciprofloxacin formulations including Linhaliq are also product
candidates for treatment of patients with cystic fibrosis and
non-tuberculous mycobacteria, and for the prevention and treatment of
high threat and bioterrorism infections, such as inhaled tularemia,
pneumonic plague, melioidosis, Q fever and inhaled anthrax.
More information about Aradigm can be found at www.aradigm.com.
Except for the historical information contained herein, this news
release contains forward-looking statements that involve risk and
uncertainties, including the ability of animal results to predict
efficacy in humans, as well as the other risks detailed from time to
time in the Company's filings with the Securities and Exchange
Commission (SEC), including the Company's Annual Report on Form 10-K for
the year ended December 31, 2016 filed with the SEC on March 30, 2017,
and the Company's Quarterly Reports on Form 10-Q.
Aradigm, Pulmaquin, Lipoquin and the Aradigm Logo are registered
trademarks of Aradigm Corporation.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170815005299/en/
Nancy Pecota, 510-265-8800
Source: Aradigm Corporation
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