Aradigm Corporation (Nasdaq:ARDM) ("Aradigm" or the "Company") today
announced the dosing of the first patient in the ORBIT-4 (Once-daily
Phase III pivotal clinical trial of Aradigm's proprietary formulation of
inhaled ciprofloxacin (Pulmaquin®) for the treatment of non-cystic
fibrosis bronchiectasis (non-CF BE). ORBIT-4 is the second of the two
Phase III pivotal clinical trials Aradigm is conducting with Pulmaquin
in non-CF BE. The Company announced the dosing of the first patient in
the ORBIT-3 clinical trial in April 2014.
The first patient in ORBIT-4 was dosed by respiratory physician Dr.
Shari Brazinsky at the Institute of HealthCare Assessment, Inc. in San
Diego. "Pulmonary exacerbations in bronchiectasis patients are always a
concern as they have an immediate adverse impact on their lives and
further worsen their health long term. A treatment that would cause a
reduction in the frequency and severity of pulmonary exacerbations in
this disease would be highly desirable," said Dr. Brazinsky.
"Both of our Phase III trials are now globally proceeding. The QIDP
Designation will provide us with the opportunity for expedited
regulatory interactions to make a potential new treatment for non-cystic
fibrosis bronchiectasis more expeditiously available to many patients
with this severe condition," said Juergen Froehlich, MD, Chief Medical
Officer of Aradigm.
The Phase III clinical program for Pulmaquin in BE consists of two
worldwide, double-blind, placebo-controlled pivotal trials (ORBIT-3 and
ORBIT-4) that are identical in design except for a pharmacokinetics
sub-study to be conducted in one of the trials. Each trial is enrolling
approximately 255 patients into a 48 week double blind period consisting
of 6 cycles of 28 days on treatment with Pulmaquin or placebo plus 28
days off treatment, followed by a 28 day open label extension in which
all participants will receive Pulmaquin (total treatment duration
approximately one year). The superiority of Pulmaquin vs. placebo during
the double blind period is being evaluated in terms of the time to first
pulmonary exacerbation (primary endpoint), while key secondary endpoints
include the reduction in the number of pulmonary exacerbations and
improvements in the quality of life measures. Lung function is being
monitored as a safety indicator.
"Our experience from recent international meetings confirms that
non-cystic fibrosis bronchiectasis is a serious, growing healthcare
problem. The pulmonary infections with Pseudomonas aeruginosa are
of particular concern in this patient population. We have established a
network of multi-national international collaborations to help us in the
execution of the ORBIT-3 and 4 trials," said Igor Gonda, President and
CEO of Aradigm.
Bronchiectasis is a severe, chronic and rare disease characterzed by
abnormal dilatation of the bronchi and bronchioles, frequently
associated with chronic lung infections. It is often a consequence of a
vicious cycle of inflammation, recurrent lung infections, and bronchial
wall damage. Non-CF BE represents an unmet medical need with high
morbidity and mortality that affects more than 110,000 people in the
U.S. and over 200,000 people in Europe. There is currently no drug
approved for the treatment of this condition.
Ciprofloxacin, available in oral and intravenous formulations, is a
widely prescribed antibiotic. It is used to treat acute lung infections
and is often preferred because of its broad-spectrum antibacterial
activity against various bacteria, such as Pseudomonas aeruginosa.
Pulmaquin is a dual release formulation composed of a mixture of
liposome encapsulated and unencapsulated ciprofloxacin. It is being
evaluated in two Phase III studies to determine its safety and
effectiveness as a once-a-day inhaled formulation for the chronic
treatment of non-CF BE.
Pulmaquin has been tested in preclinical safety studies (up to 3 months
in rodents and 9 months in dogs).
Following Phase 2a development of the liposomal portion of Pulmaquin and
phase 1 development of Pulmaquin, the phase 2b study ORBIT-2 with
Pulmaquin was a 24-week multicenter, randomized, double-blind,
placebo-controlled trial in 42 adult non-CF bronchiectasis
subjects. This study demonstrated a significant reduction in P.aeruginosa
sputum activity (P =0.002) and a decrease in time to first exacerbation
in the per protocol population (p=0.046) and the mITT (p=0.057)
populations in the Pulmaquin treated subjects compared to placebo.
Overall, the incidence of all treatment emergent adverse events was
similar between groups. The most frequently reported treatment related
adverse events (reported by = 3 patients in either treatment group)
included product taste abnormal and nausea in the Pulmaquin group and
wheezing in the placebo group. No serious adverse events were considered
treatment related. There were no deaths reported during ORBIT-2.
Aradigm has been granted orphan drug designations for inhaled liposomal
ciprofloxacin as well as for inhaled free ciprofloxacin for non-CF
bronchiectasis in the U.S. In addition, the U.S. Food and Drug
Administration (FDA) has designated Pulmaquin as a Qualified Infectious
Disease Product (QIDP). The QIDP designation is granted for treatment of
non-cystic fibrosis bronchiectasis (non-CF BE) patients with chronic
lung infections with Pseudomonas aeruginosa.
In 2013, Aradigm granted an exclusive, world-wide license for the
Company's inhaled liposomal ciprofloxacin product candidates for the
indication of non-CF BE and other indications to Grifols S.A. More
information on the terms of this license may be found in the Company's
Annual Report on Form 10-K for the year ended December 31, 2013 filed
with the SEC on March 13, 2014.
Aradigm is an emerging specialty pharmaceutical company focused on the
development and commercialization of drugs delivered by inhalation for
the prevention and treatment of severe respiratory diseases. Aradigm has
product candidates addressing the treatment of non-CF BE, cystic
fibrosis and prevention of respiratory and other diseases in tobacco
smokers through smoking cessation. Aradigm is also developing Pulmaquin
and a liposomal ciprofloxacin formulation as potential medications for
the prevention and treatment of high threat and bioterrorism infections,
such as inhaled tularemia, pneumonic plague, Q fever and inhaled anthrax.
Aradigm has been granted orphan drug designations for liposomal
ciprofloxacin for cystic fibrosis (CF) in the U.S. and the E.U., and
liposomal ciprofloxacin and free ciprofloxacin for inhalation for the
management of bronchiectasis in the U.S.
Disclaimer and Forward-Looking Statements
The facts and figures contained in this news release which do not refer
to historical data are "projections and forward-looking statements'".
The words and expressions like "believe", "hope", "anticipate",
"predict", "expect", "intend", "should", "try to achieve", "estimate",
"future" and similar expressions, insofar as they are related to
Aradigm, the prospects for Aradigm's inhaled ciprofloxacin product
formulations to successfully complete clinical trials and to result in
approved products, and the ability of Grifols to successfully
commercialize these products, are used to identify projections and
forward-looking statements. These expressions with respect to Aradigm
reflect the assumptions, hypothesis, expectations and anticipations of
the management team of Aradigm at the date of preparation of this news
release, which are subject to a number of factors that could make the
real results differ considerably, such as the uncertainties associated
with clinical trials including lack of effectiveness, lack of
statistical significance of results, adverse side effects or other
safety issues, uncertainties regarding the process of obtaining
regulatory approval for the sale of new drugs, uncertainties concerning
the development of demand for new products, uncertainties regarding the
level of reimbursement for new products, manufacturing and supply issues
and the like. Except for the historical information contained herein,
this news release contains forward-looking statements that involve risk
and uncertainties detailed from time to time in Aradigm's filings with
the Securities and Exchange Commission (SEC), including its Annual
Report on Form 10-K for the year ended December 31, 2013 filed with the
SEC on March 13, 2014, and Aradigm's Quarterly Reports on Form 10-Q.
Aradigm, Pulmaquin and the Aradigm Logo are registered trademarks of
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