Aradigm Corporation’s experimental therapy Pulmaquin, an inhaled antibiotic for the treatment of non-cystic fibrosis bronchiectasis, was recently given the Qualified Infectious Disease Product (QIDP) designation from the U.S. Food and Drug Administration (FDA). The drug specifically targets non-cystic fibrosis bronchiectasis patients who suffer from chronic Pseudomonas aeruginosa infections.
For Aradigm and non-CF BE patients alike, the QIDP designation is significant, since it will now allow Pulmaquin and the company to take advantage of certain drug development incentives that the FDA makes available for the creation of new antibiotics through their Generating Antibiotic Incentives Now Act (GAIN Act), such as fast-tracked, priory review of study results. It also means that Pulmaquin will be eligible for an additional five-year exclusivity period should Pulmaquin win approval from the FDA.
Currently, Aradigm is in the enrollment process for a wide-ranging Phase III clinical trial that tests the drug on non-CF BE participants. Recently, BioNews Texas reported on how the company had dosed its first participant with the drug in the ORBIT-3 branch of the study. The trial consists of both ORBIT-3 and ORBIT-4, which are two double-blind, placebo-controlled pivotal trials being conducted worldwide that use identical methods with the exception of a pharmacokinetics component added into one of the two trials. In total, each clinical trial will include around 255 patients who will participate in a 48-week double blind period that will consist of 6 cycles of 28 days of either Pulmaquin treatment or a placebo, plus 28 days off treatment. After this period, Aradigm will offer a 28-day open label extension of the trials, which will allow all participants in the study to gain access to Pulmaquin for about a year.
The primary endpoint of the ORBIT studies will be to test how Pulmaquin performs against the placebo by measuring the time it takes for participants to experience their first pulmonary exacerbation. There will also be secondary endpoints for the study, which will include reduction in the number of pulmonary exacerbations and improvements in the quality of life measures. The safety of the drug will be determined by monitoring lung function.
“We are very pleased that the FDA has granted QIDP designation to Pulmaquin,” said Igor Gonda, Chief Executive Officer of Aradigm Corporation. “Persistent lung infections with Pseudomonas aeruginosa are a key factor related to the poor quality of life and untimely death in non-cystic fibrosis bronchiectasis patients. The QIDP designation will accelerate the advancement of Pulmaquin development as a potential treatment for these patients.”