Wednesday, Aradigm Corp. (ARDM.OB) announced positive top-line results from a Phase 2 clinical trial of inhaled liposomal ciprofloxacin hydrochloride, or ILCH, in patients with non-cystic fibrosis bronchiectasis. The company said the trial met the primary efficacy endpoint.
The primary efficacy endpoint of the study was the change from baseline in the sputum Pseudomonas Aeruginosa colony forming units, which measured the reduction in pulmonary bacterial load. Patients in both the test groups demonstrated significant mean decreases against the baseline in the bacterial colony forming units.
The open-label, four-week treatment study was conducted at eight centers in the United Kingdom, with a total of 36 patients. The patients were randomized into two groups, each receiving 3 mL and 6 mL dosages of the drug.
The company said the drug was well tolerated, though three serious adverse events were observed in each dose group.
Igor Gonda, the company's Chief Executive Officer and President, said, "We are making significant clinical advances in the development of valuable medicines for the prevention and treatment of severe respiratory diseases. We will continue to work with the regulatory authorities to complete the plans for the remaining development of ILCH."
Earlier, a Phase 2a study of ILCH in patients with cystic fibrosis, demonstrated significant reductions in respiratory infections, as measured by the bacterial population in the patient's sputum and improvement of lung function.
The company is also developing ILCH for the prevention and treatment of bioterrorism infections such as inhaled anthrax.
ARDM.OB closed Tuesday's regular trade at $0.29.
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