AmpliPhi Biosciences has completed enrollment for a Phase 1 clinical trial to evaluate the safety of AB-SAB01, its proprietary bacteriophage cocktail against Staphylococcus aureus (S. aureus) infections.
Despite strong eradication efforts, S. aureus remains one of the most common causes of hospital-acquired infections, including pneumonia.
AmpliPhi Biosciences is conducting the trial under a Collaborative Research and Development Agreement with the U.S. Army at the Walter Reed Clinical Trials Center in Silver Spring, Maryland. Topline results are expected by the end of September.
The double-blind, placebo-controlled study, launched on May 24, was designed to evaluate the safety of AB-SA01 when administered topically to the skin of 12 healthy adult volunteers ages 18 to 60. The study split the volunteers into two cohorts of six participants each, and gave one group a low dose and another group a high dose of the drug candidate, administered to the forearm under an air- and water-tight bandage.
The participants were their own controls, as a placebo was also administered topically to the volunteers’ opposite forearms. AB-SA01 was administered for three consecutive days, and all volunteers were monitored after treatment.
“Successfully enrolling the first U.S.-based trial of AB-SA01 marks a signal achievement by the AmpliPhi team and our partners at Walter Reed as we work to pioneer the first rigorous human efficacy studies of phage therapy in the United States,” AmpliPhi CEO M. Scott Salka said in a press release.
“Phage therapy holds the potential to play a critical role in humanity’s fight against the looming and ever-evolving threat of antibiotic-resistant bacteria by exploiting a predator-prey relationship that has been raging since the dawn of life on Earth. We look forward to completing the necessary follow-up visits and providing more results soon, and expect to have complete study reports for both this trial as well as our Phase 1 AB-SA01 trial in patients with chronic rhinosinusitis later this year,” Salka said.
Bacteriophages (or phages) are viruses that occur naturally that have evolved to be highly selective for the bacterial species they must infect so they can replicate. A successful infection enables a single phage to hijack a bacterial host’s protein production machinery to rapidly produce hundreds of progeny phages. At this point, the phage makes bacterial cells burst, scattering the highly selective progeny into the surrounding environment to attack nearby bacteria and continue repeating the process until there are no more bacteria.
This process allows phages to sustain their bacterial species selectively, enabling a phage-based therapeutic approach to precisely target a pathogenic bacterial population while keeping the good microbiota.