BioPhage-PA / Otitis

AmpliPhi Bioscience’s BioPhage-PA is a bacteriophage therapeutic for the treatment of Pseudomonas aeruginosa infections that occur in chronic ear disease and other topical infections, particularly those that are not responsive to antibiotic therapy.

About Otitis

Human infections of the outer ear (otitis externa, known as “swimmer’s ear”) are common. Pseudomonas aeruginosais a major cause of these infections as well as of infections of the middle ear (otitis media). In diabetics, malignant otitis externa and otitis media can lead to paralysis and even be life-threatening. An estimated 1.25 percent of the population is affected by otitis externa every year, and of these 3 percent are referred to secondary care at specialist ear, nose and throat (ENT) centers. Rates of otitis media of 0.6% of the population have been reported for the United Kingdom, and these can be higher elsewhere. A substantial market also exists in the long-term care of bacterial infection in patients with surgically created mastoid cavities. Treatment of severe otitis often requires the use of aminoglycoside antibiotics, which can cause damage to hearing.

Clinical Results

Published data from a Phase 2 clinical trial demonstrate the efficacy of BioPhage-PA in the treatment of serious bacterial infections: specifically, the treatment of Pseudomonas aeruginosa in chronic adult inflammation or infection of the ear (otitis).

The trial, which was conducted in 24 patients with chronic ear infections of a duration of several years (range: 2-58 years), showed complete resolution of infection in 25 percent (and some improvement in 92 percent) of treated patients following a nanogram-range single dose treatment of Biophage-PA. The study showed a statistically significant improvement in microbiological indicators (Wright et al, Clinical Otolaryngology. 2009 Aug; 34 (4): 349-57.  The treatment appeared safe and well-tolerated. Among the most striking of the trial’s findings were the bacterial counts, analysed from samples taken from patients’ ears at periods of one, three and six weeks after the treatment was applied.  In the test group of patients, the mean count of Pseudomonas aeruginosa bacteria present dropped by an average of around 80 percent by week three, and stayed there.  By contrast, in the control group, the mean levels of bacteria showed a 10 percent increase over the same period.