"I am very pleased that the encouraging effects of Lipoquin and
Pulmaquin against PNTM in the biofilm and macrophage in vitro assays
have been now confirmed with this short treatment in our animal model.
This test system was previously evaluated and demonstrated to provide
results comparable to the results obtained in humans. We expect that
even more profound effects will be seen with the prolonged treatment
over several months typically used in humans," said Dr.
The detailed description of this research and its findings will be
presented at Session D108 entitled "Diagnosis and Management of
Nontuberculous Mycobacteria Infections" at
The research reported in this publication was supported by the
About Pulmonary Non-Tuberculous Mycobacteria (PNTM) Infections
NTM is found almost everywhere - for example, in tap water and the soil. People with severe pulmonary diseases including cystic fibrosis, chronic obstructive pulmonary disease (COPD), and Alpha-1 Antitrypsin deficiency are particularly vulnerable to PNTM infections. PNTM symptoms include: fever, cough (including coughing up blood), weight loss/loss of appetite, fatigue and night sweats. Bronchiectasis is a frequent co-morbidity in these patients.
PNTM patients are treated with antibiotics. Some species of mycobacteria may be resistant to certain antibiotics and the antibiotics may cause side effects that require stopping the treatment. Treatment may last more than one year.
A publication from the
About Aradigm's Pulmaquin and Lipoquin investigational product candidates
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 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).
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.
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