Aradigm Corporation Announces the Dosing of the First Patient in Phase III
Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-3)
Aradigm’s Pulmaquin - A Potential New Therapy to Treat an Unmet Medical Need
in Patients with Severe Respiratory Disease
HAYWARD, Calif. -- April 30, 2014
Aradigm Corporation (OTCBB:ARDM.OB) (“Aradigm” or the “Company”) today
announced the dosing of the first patient in the ORBIT-3 (Once-daily
Respiratory Bronchiectasis Inhalation Treatment) Phase III pivotal clinical
trial of Aradigm’s proprietary formulation of inhaled ciprofloxacin
(Pulmaquin®) for the treatment of non-cystic fibrosis bronchiectasis (non-CF
The first patient was dosed by respiratory physician Dr. Douglas Fiedler at
Nebraska Pulmonary Specialties, LLC. “I am very pleased to participate in this
study to investigate the potential benefits of a new medication for my
patients with a chronic debilitating respiratory disease for which we do not
have any good evidenced-based treatments yet,” said Dr. Fiedler.
“With our Phase III trials under way now, it is gratifying that many
clinicians around the world will be joining our effort to find a treatment for
an unmet medical need in patients with the severe condition of non-cystic
fibrosis bronchiectasis,” said Juergen Froehlich, MD, Chief Medical Officer of
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 will enroll 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 will be 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 will be monitored
as a safety indicator.
“The start of the Phase 3 program in non-CF BE is marking the accomplishment
of a critical milestone for Aradigm,” said Igor Gonda, President and CEO of
Aradigm. “We are grateful for the interest of patients with this disease to
participate in this program, as well as for the support that we have been
receiving from the COPD Foundation Bronchiectasis Consortium Registry.”
Bronchiectasis is a severe, chronic and rare disease characterized 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
110,000people 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 designation for the combination of
liposomal ciprofloxacin and free ciprofloxacin for inhalation for the
management of bronchiectasis in the U.S.
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
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 Aradigm
Nancy Pecota, 510-265-8800
Aradigm Chief Financial Officer
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