Aradigm Corporation is collaborating with the University of Sydney in Australia to develop nanotechnologies targeting fungal and bacterial biofilms, a common complication of infections associated with chronic diseases like cystic fibrosis (CF) and non-CF bronchiectasis (non-CF BE).
In total, $420,000 AUD (around $318,000 U.S.) will be allocated to the project over three years by the Australian Research Council through the Australian Linkage Project program.
“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,” said Professor Daniela Traini, with the Woolcock Institute, University of Sydney Medical School, and the project’s leader, in a press release.
“Biofilms are not only ubiquitous, they exhibit a recalcitrance to control. According to the NIH [National Institutes of Health], more than 60% of all microbial infections are caused by biofilms. While acute infections involving motile bacteria are generally treatable with antibiotics and antifungals, once a biofilm is established the infection is often untreatable,” Traini said.
Aradigm is focused on the development of therapies for the prevention and treatment of severe respiratory diseases.
“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. Our colleagues at the Woolcock Institute have world class expertise and equipment to study the effect of nanotechnologies on biofilms. 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,” said David Cipolla, PhD, vice president, pre-clinical R&D, Aradigm.
Aradigm’s liposome formulations are nano-size vesicles made of lipids, which can deliver drugs directly into the respiratory tract, offering targeted delivery of treatments to minimize potential side effects.
The company is currently conducting advanced clinical trials into the safety and efficacy of Pulmaquin, a dual release formulation combining liposome encapsulated and unencapsulated ciprofloxacin, which is a broad-spectrum antibiotic used to fight bacterial lung infections. The drug is being tested in non-CF BE patients.
Phase 1 and 2 studies have shown that Pulmaquin can decrease P. aeruginosa sputum activity and reduce the time to first exacerbation, in comparison to placebo treatment.
Aradigm recently completed dosing of non-CF BE patients in two Phase 3 trials on Pulmaquin — ORBIT 3 (NCT01515007) and ORBIT-4 (NCT02104245). The trials are assessing Pulmaquin, compared with placebo, in terms of the time to first pulmonary exacerbation (primary endpoint), and reduction in pulmonary exacerbations number and improvements in quality of life measures (secondary endpoints).
The U.S. Food and Drug Administration (FDA) classified Pulmaquin a Qualified Infectious Disease Product (QIDP) for non-CF BE patients with chronic lung infections with P. aeruginosa, and, in 2014, granted it Fast Track designation, which provides incentives to more quickly move an investigative treatment through the regulatory process.