Polyphor and the European Innovative Medicines Initiative (IMI) will fund up to 10 million euros (around $11.6 million U.S.) to support and advance the development of an inhaled formulation of Polyphor’s investigational antibiotic murepavadin (POL7080).
Polyphor is investing 5 million euros into the development project; the IMI will provide up to 5 million.
Cystic fibrosis and bronchiectasis patients are especially affected by respiratory infections caused by drug-resistant bacteria. In the past, the availability of inhaled antibiotics increased the survival and offered a better quality of life for these patients. But it is imperative to develop new lifesaving antibiotic treatments to manage chronic lung infections and fight resistant pathogens.
Murepavadin is a specific antibiotic that targets Gram-negative bacteria. It is known as a precision outer membrane protein targeting antibiotic (OMPTA) against one of the most difficult pathogens to treat, Pseudomonas aeruginosa bacteria. This antibiotic is also highly potent against other multi-drug resistant strains.
Murepavadin has been used as an intravenous formulation in previous European-based clinical trials. The new inhaled formulation could be used to treat long-lasting infections by P. aeruginosa in patients with cystic fibrosis, non-cystic fibrosis bronchiectasis, and other rare lung diseases.
“Our investigational antibiotic reaches high concentration in the lung and shows a high efficacy against Pseudomonas aeruginosa, the main cause of chronic lung infections in cystic fibrosis, affecting the majority of patients,” Giacomo Di Nepi, CEO of Polyphor, said in a press release.
“In addition, by targeting only Pseudomonas aeruginosa, murepavadin does not induce further resistance in other pathogens, which could infect these patients,” Di Nepi added.
IMI is a public-private partnership of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Union Commission. In November 2011, the EU launched its first Action Plan against the rising threat from antimicrobial resistance. IMI then launched “The New Drugs for Bad Bugs” (ND4BB) program in response to this call from the EU to develop novel antibiotic treatments to manage chronic lung infections.
The Inhaled Antibiotics in Bronchiectasis and Cystic Fibrosis (iABC) is part of the ND4BB program. It’s an EU consortium of leading lung specialists in 18 hospitals and research institutions in eight European countries, including industry partners Polyphor and Novartis.
“Our work has the potential to deliver new inhaled antibiotics that will improve the quality of life and survival of patients with cystic fibrosis and bronchiectasis by reducing the number of lung infections, improving lung function, and overcoming antibacterial resistance,” said Stuart Elborn, professor of respiratory medicine at the Royal Brompton Hospital in London and principal investigator of the murepavadin inhaled antibiotic project. Royal Brompton Hospital is one of the iABC partners.
Pivotal studies of murepavadin’s intravenous formulation will enter Phase 3 clinical trials in early 2018. These trials will test the therapy in patients with nosocomial pneumonia (ventilator-associated and hospital-acquired pneumonia) caused by P. aeruginosa, including its resistant strains. These studies were previously approved by the U.S. Food and Drug Administration and the European Medicines Agency.
The FDA has granted Qualified Infectious Disease Product status to murepavadin, placing the antibiotic candidate on an accelerated track for approval. This FDA designation is reserved for innovative medicines to treat life-threatening conditions.