Aradigm's Pulmaquin - A Potential New Therapy to Treat an Unmet Medical Need in Patients with Severe Respiratory Disease
The worldwide, double-blind, placebo-controlled pivotal trial enrolled
304 patients across 16 countries, including the U.S.,
"The completion of enrollment in the first of our Phase III clinical
trials is a major milestone in the development of our investigational
formulation Pulmaquin. We sincerely thank our investigators and the
patients with non-CF BE for participating in this important clinical
trial which aims to decrease the substantial disease burden due to
chronic lung infections with P. aeruginosa by reducing their
frequency and improving the quality of life of these patients," said
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. The dosing regimen for each trial consists of a 48 week double blind period of 6 cycles of 28 days on treatment/28 days off treatment with Pulmaquin or placebo, followed by a 28 day open label extension in which all participants will receive Pulmaquin. 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, including severe episodes, and improvements in specific quality of life measures. Lung function is being monitored as a safety indicator.
Bronchiectasis is a severe, chronic and rare disease characterized by bronchial wall damage diagnosed as abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections and a vicious cycle of inflammation and episodes of acute worsening. In these severely affected adult patients, infections with Pseudomonas aeruginosa are associated with an approximately 3-fold increased risk of death and an increase in hospital admissions and exacerbations. Non-CF BE represents an unmet medical need 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 to prevent pulmonary exacerbations.
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 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) 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.
Aradigm has been granted orphan drug designations for liposomal ciprofloxacin as well as for ciprofloxacin for inhalation for non-CF BE in the U.S. In addition, the U.S. Food and Drug Administration (FDA) has designated Pulmaquin as a Qualified Infectious Disease Product (QIDP) for treatment of non-CF BE patients with chronic lung infections with Pseudomonas aeruginosa. The QIDP designation made Pulmaquin eligible for Fast Track designation which was granted by the FDA in September 2014.
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 is currently in Phase
3 development of Pulmaquin (an investigational proprietary formulation
of ciprofloxacin for inhalation) for the treatment of non-cystic
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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