Event Will Feature Presentations by KOLs David Griffith, MD, and
Aradigm's executive management team will provide a corporate overview, including an update on the development program for Pulmaquin® - Aradigm's proprietary inhaled antibiotic product candidate currently completing two global Phase 3 clinical trials in non-CF BE patients.
Attendance at the Analyst Meeting is limited to institutional investors,
investment bankers and analysts. To reserve a space, please contact
The presentations, followed by a question-and-answer session, will be
webcast live beginning at
Pulmaquin is a dual release formulation 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 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 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 patients with non-CF BE who have chronic lung infections with Pseudomonas aeruginosa.
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 has enrolled patients (278 in ORBIT-3 and 304 in ORBIT-4) 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, including the double-blind period, of 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
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
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