Twenty-one patients in seven hospitals with severe, life-threatening bacterial infections that were unresponsive to antibiotics were given phage preparations against Staphylococcus aureus or Pseudomonas aeruginosa as part of an open-access program.

As a reminder, expanded access programs (EAPs) allow pharmaceutical companies to offer medications to patients before they are approved by government health authorities in their country of residence. In the US, the FDA grants approval for an EAP in the following cases:

- patients with a serious or life-threatening illness;

- patients for whom there are no other satisfactory treatment options.

Since mid-2017, the EAP has been ongoing in the United States and Australia, with patients receiving phage preparations AB-SA01 (against S. aureus ) or AB-PA01 (against P. aeruginosa ) produced by AmpliPhi Biosciences. During this period, more than 1,000 doses of phage preparations were administered to 21 patients with severe, life-threatening bacterial infections that were unresponsive to antibiotic treatment. Fifteen patients were treated with S. aureus and six with P. aeruginosa . The patients experienced bacteremia, endocarditis, recurrent pneumonia, ventilator-associated pneumonia, artificial joint infections, heart pump infections, and other conditions.

Over 400 doses of the AB-SA01 phage preparation were administered as part of the program, including over 300 doses administered intravenously. All patients tolerated the treatment well, and no serious side effects were observed.

Over the course of the program, more than 600 doses of the AB-PA01 phage preparation were administered, including over 400 doses intravenously. Five of the six patients tolerated the treatment well. One patient discontinued treatment due to a side effect, which resolved within 18 hours. No serious side effects were observed.

In 84% of patients, the treatment was effective: complete disappearance of disease symptoms or significant improvement in condition was achieved.

According to Dr. Jonathan Iredell, an infectious disease physician at Westmead Hospital in Sydney and a professor of medicine and microbiology at the University of Sydney (Australia), these results provide further support for the safety and effectiveness of phage therapy, which is planned to be proven in randomized controlled clinical trials.