US-based biotechnology firm AmpliPhi Biosciences has started dosing patients in its Phase l clinical trial to evaluate the safety of AB-SA01 in treating Staphylococcus aureus (S. aureus) infections.
S. aureus is a major cause of skin and soft tissue infections and particularly affects individuals with underlying health conditions.
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The disease could harm patients with damaged immune systems, burns and surgical wounds.
The double-blind, ascending dose trial is being conducted under a collaborative research and development agreement with the US Army at the Walter Reed Army Institute of Research Clinical Trials Centre in Silver Spring, Maryland, US.
The trial is designed to evaluate the safety of AB-SA01 given topically to the skin of up to six healthy adult volunteers between the ages of 18 and 60 years in each of two dose cohorts.
Enrolled subjects in the low and high-dose cohorts will receive either one 108 or one 109 PFU/ml of AB-SA01 respectively, given topically to the forearm with an occlusive bandage.
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By GlobalDataPlacebo will also be given to the opposite forearm, allowing each participant to serve as his or her own control.
The participants will receive AB-SA01 and placebo daily for three consecutive days and will be followed for ten to 14 days after the final treatment.
AmpliPhi Biosciences CEO M Scott Salka said: "Harnessing the natural predators of bacteria to conquer infections is a radically new therapeutic strategy that has the potential to deliver a new generation of medicines to treat antibiotic-resistant infections, and to do so without destroying a patient’s microbiome, or the trillions of beneficial bacteria critical to good health.
"Our preclinical data demonstrates that AB-SA01 effectively kills a variety of S. aureus strains, including those resistant to methicillin.
"I would like to thank Jeffrey Livezey, MD, MSc, MAJ, MC, deputy director of clinical pharmacology at Walter Reed Army Institute of Research and the principal investigator of this study, along with his entire team for their support and hard work.
"I am extremely proud of the AmpliPhi team and our partners for the accomplishment of starting two clinical trials during the first half of 2016, putting us on track to announce data from both trials later this year."
The company is currently conducting a Phase l clinical trial of AB-SA01 to treat S. aureus in chronic rhinosinusitis patients.
Image: Microscopic image of staphylococcus aureus. Photo: courtesy of Y Tambe.
