Aradigm Corporation announced a collaboration with the University of Sydney to develop a program of advanced nanotechnologies to treat bacterial and fungal biofilms — aggregates of pathogens that adhere and settle on the surface of organs — often found in chronic diseases like cystic fibrosis (CF) and non-CF bronchiectasis (non-CF BE).
The collaboration was awarded $420,000 AUD (around $318,000 U.S.) by the Australian Research Council through the Australian Linkage Project program. The funding will support the research program for a period of three years.
“The adverse impact of bacterial and fungal biofilms in the medical field including medical devices, organ transplantation and many severe infections with organisms such as Pseudomonas aeruginosa and non-tuberculous mycobacteria, is a significant problem,” Daniela Traini, with the University of Sydney School of Medicine and the program’s lead researcher, said in a news release.
According to Traini, biofilms can be the cause of many infections. But while acute infections with motile bacteria can be treated with antibiotics and antifungals, infections caused by biofilms are resistant to therapies.
“We are grateful that the Australian government has chosen to fund this important collaborative program on biofilms which may lead to beneficial treatments for patients with severe lung infections,” said David Cipolla, PhD, vice president of Aradigm. “These efforts build upon the body of knowledge that has already accumulated through Aradigm’s development of inhaled liposomal ciprofloxacin formulations for treatment of severe lung infections.”
Aradigm recently reported that the dosing of patients is complete in two Phase 3 studies [ORBIT-3 (NCT01515007) and ORBIT-4 (NCT02104245)] evaluating the effectiveness and safety of Pulmaquin in non-CF BE patients with chronic lung infections cause by P. aeruginosa. Both studies are analyzing a 48-week treatment with Pulmaquin or placebo based on six cycles of 28 days of treatment, followed by 28 days of no treatment, and a 28-day open-label extension in which all participants receive Pulmaquin. The trials’ endpoints the time to first pulmonary exacerbation, number of pulmonary exacerbations, and improvements in quality of life measures.
Results from a previous Phase 2b trial, ORBIT-2, showed that treatment with Pulmaquin for 24 weeks in 42 adult non-CF BE patients induced a significant reduction in P. aeruginosa activity in the sputum (‘coughed-up’ mucus from the trachea and bronchi), and a reduction in the time to first exacerbation compared to placebo. Most frequent side effects reported included abnormal taste and nausea.
Pulmaquin is composed of liposome encapsulated and unencapsulated ciprofloxacin, an antibiotic that is used in the treatment of acute and chronic lung infections caused by a broad-spectrum group of bacteria, including P. aeruginosa.
Pulmaquin was designated a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) for the treatment of non-CF BE patients with chronic P. aeruginosa lung infections, and, in 2014, granted Fast Track designation by the FDA.