Event Will Feature a Presentation by KOL David Griffith, MD
Dr. Griffith's current research interests include the epidemiology and
treatment of nontuberculous mycobacteria (NTM) diseases, and
pathogenesis and treatment of bronchiectasis - a frequent co-morbidity
in pulmonary NTM infections. He is author or co-author on more than 180
publications, including original peer reviewed manuscripts, book
chapters, reviews, editorials, and electronic publications. His main
areas of interest have been the study of mycobacterial diseases, with an
emphasis on NTM diseases in patients with bronchiectasis. He has
participated in clinical trials and research projects that have resulted
in the establishment of treatment standards for NTM disease patients. He
was also the principal author for the most recent
Aradigm's executive management team will provide a corporate overview, including an update on the development program for the investigational drug Pulmaquin® - Aradigm's proprietary inhaled antibiotic product candidate currently in two Phase 3 clinical trials in non-CF BE patients.
Attendance at the Key Opinion Leader Breakfast is limited to
institutional investors and analysts. To reserve a space, please contact
The presentation, followed by a question-and-answer session, will be
webcast live beginning at
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 an investigational dual release formulation composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. It is being evaluated in two ongoing Phase 3 studies to determine its safety and effectiveness as a once-a-day inhaled formulation for the chronic treatment of non-cystic fibrosis bronchiectasis (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 (Lipoquin®) 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 BE 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.
The Phase 3 clinical program for Pulmaquin in non-CF 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.
About Non-Cystic Fibrosis Bronchiectasis
Non-CF BE 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 110,000 people in the
U.S. and over 200,000 people in
More information about
Except for the historical information contained herein, this news
release contains forward-looking statements that involve risk and
uncertainties, including those related to the ORBIT-3 and ORBIT-4
clinical trials and the ability to continue successful product
development of our potential product candidates, including Pulmaquin, as
well as the other risks detailed from time to time in the Company's
filings with the
Chief Financial Officer
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