Study shows bacteriophages remain active against P. aeruginosa infection after nebulization

Results presented at the 38th European Cystic Fibrosis Conference

AmpliPhi BioSciences Corporation (OTCQB: APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug resistant infections, today announced new data demonstrating that bacteriophages remain active against Pseudomonas aeruginosa (P. aeruginosa) after nebulization. Data from this study, performed in collaboration with the Royal Brompton Hospital and Imperial College, UK, were presented at the 38th European Cystic Fibrosis Conference, taking place in Brussels, Belgium from June 10-13.

To determine if nebulization might provide a viable delivery option for AmpliPhage-001, AmpliPhi's program targeting P. aeruginosa infections in Cystic Fibrosis (CF) patients, researchers evaluated the biological activity of four different bacteriophages after nebulization through three commercially available nebulizers. Phages were collected downstream and their biological activity post-nebulization assessed in a standard plaque assay using two P. aeruginosa indicator strains. Phages exposed to non-functioning nebulizer chambers were used as controls. The results showed that all four anti-P. aeruginosa bacteriophages retained their biological activity through all of the nebulizers tested and minor titre drops were within variability of the methodology, confirming that this mode of administration may therefore be appropriate for future clinical trials.

"We are encouraged by these promising results, indicating that the biological activity of bacteriophage against P. aeruginosa infection is retained following delivery through nebulization," said M. Scott Salka, CEO of AmpliPhi. "Demonstrating this proof-of-concept represents an important milestone in our AmpliPhage-001 program, as therapeutic administration through nebulization increases the probability that critical areas of the lung can be directly reached with phages in patients with cystic fibrosis."

The research teams had previously established the safety and efficacy of nasally-inhaled bacteriophage against P. aeruginosa in a murine model, noting reduced infective burden and inflammatory response demonstrated in bronchoalveolar lavage. Based on these positive data, AmpliPhi plans to advance its AmpliPhage-001 program, with delivery via nebulization, towards human clinical trials anticipated to commence in 2016.

P. aeruginosa infections account for the highest rate of mortality in cystic fibrosis patients, show a high degree of antibiotic resistance and have been historically difficult to treat. Earlier this year, AmpliPhi was granted a European patent covering various bacteriophage preparations for use in combination with antibiotics for the treatment of biofilm-related infections caused by P. aeruginosa.

"Frequent lung infections with high potential for antibiotic resistance are a common comorbidity in cystic fibrosis patients and represent a high unmet medical need with no optimal treatment," continued Mr. Salka. "These data further validate the potential of nebulized phage therapy as a new treatment option for more than 70,000 patients worldwide affected by this debilitating and life threatening disease".