CRS is defined as a serious, often debilitating infection and inflammation of the nose and sinuses lasting 12 weeks or more. AmpliPhi's first Phase 1 clinical trial focused on CRS patients whose S. aureus infections had rebounded following antibiotic treatment and sinus surgery. Final results from the trial showed that AB-SA01 met the trial's primary endpoints of safety and tolerability. All nine patients enrolled in the study experienced a reduction in the quantity of S. aureus infecting their sinuses, with some patients showing complete eradication of their bacterial infection.
This program is being conducted in partnership with the University of Adelaide, Queen Elizabeth Hospital and Flinders University in South Australia.
Each year, there are approximately 30 million cases in the U.S. each year, with around 300,000 patients resorting to invasive surgery each year. It carries an economic burden in the US of $22 billion, of which $4.3bn is spent in direct treatment costs.
AB-SA01 has been shown to be non-invasive and to have the potential to penetrate biofilms and relieve rhinitis.
AB-SA01 is also being tested against acute and chronic wound and skin infections caused by S. aureus, including MRSA strains.
This program is being carried out under a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Medical Research and Materiel Command and the Walter Reed Army Institute of Research.
MRSA affects nearly five million people in the U.S. every year. MRSA is responsible for one of the most common causes of hospital-acquired (nosocomial) infections..
Approximately 80% of CF patients aged 25-34 are chronically infected with P. aeruginosa. These infections can lead to respiratory damage called bronchiectasis and potentially the need for lung transplants.
AB-PA01 is under final product characterization and is in nonclinical studies with Royal Brompton Hospital. We plan to move into our Phase I trial in early 2017.
Mean annual costs following initial infection increased by approximately $18,500 per patient.
AB-PA01 has already demonstrated activity of over 85% against a global panel of CF isolates, penetrated biofilm and survived nebulization.
C. difficile causes damaging infections, especially where normal bacteria have been depleted by antibiotics. It is one of the most common hospital-acquired infections and can cause severe diarrhea and physical pain. It can also limit antibiotic treatment for other conditions.
C. difficile has an annual economic burden of $4.8bn in acute care costs. In the U.S. it causes a quarter of a million hospitalizations per year and 14,000 deaths.
AB-CD01 will only target C. difficile, avoiding the effects of broadly depleting the gut microbiota. It is currently in nonclinical studies with The University of Leicester.
AB-CD01 has shown to preserve beneficial microbiome and acts as an adjunt to antibiotic therapy.