Research & Development
First Human Patient Treated with AmpliPhi Biosciences' AB-SA01 Targeting Staphylococcus Aureus
11 September 2017 - - The first-in-human intravenous administration of US-based biotechnology company AmpliPhi Biosciences Corp's (NYSE American: APHB) drug candidate AB-SA01 has been conducted, the company said.

AmpliPhi supplied AB-SA01 to a major hospital in Australia for a patient suffering from a life-threatening Staphylococcus aureus (S. aureus) infection of the heart (endocarditis).

AB-SA01 was administered intravenously to the patient over two weeks and was well tolerated.

AmpliPhi provided AB-SA01 for the patient under Category A of the Australian Therapeutic Goods Administration's Special Access Scheme.

The SAS is the TGA's framework that enables the import and supply of unapproved therapeutics on a case-by-case basis for patients who have no other satisfactory treatment options. SAS Category A is specifically designated for patients who are seriously ill with a life-threatening condition.

AB-SA01 previously completed two Phase 1 clinical trials, including one in patients with chronic rhinosinusitis, administered as a sinus wash, and one in healthy volunteers, administered topically.

In August 2017, AmpliPhi announced the first-in-human administration of its therapeutic candidate AB-PA01 targeting Pseudomonas aeruginosa (P. aeruginosa) under an emergency IND allowed by the FDA.

AmpliPhi provided AB-PA01 to a major US teaching hospital for a patient suffering from a life-threatening multidrug-resistant P. aeruginosa lung infection.

Multiple doses of AB-PA01 were administered both intravenously and by inhalation through a nebulizer and were well tolerated.

Bacteriophages, or more simply "phages," are the natural predators of bacteria and are thought to be the most abundant life form on earth.

Phages have evolved an incredible diversity of strains that typically prey upon just a few closely related strains or species of bacteria, enabling phage therapies to precisely target pathogenic bacteria while sparing the beneficial microbiota.

Phages can infect and kill bacteria, whether they are antibiotic-resistant or not, and even when they have formed protective biofilms.

AmpliPhi Biosciences is a clinical-stage biotechnology company focused on treating antibiotic-resistant infections using its proprietary bacteriophage-based technology.

The company's lead product candidates target multidrug-resistant S. aureus and Pseudomonas aeruginosa, which are included on the WHO's 2017 Priority Pathogens List.

Phage therapeutics are uniquely positioned to address the threat of antibiotic-resistance as they can be precisely targeted to kill select bacteria, have a differentiated mechanism of action, can penetrate and disrupt biofilms (a common bacterial defense mechanism against antibiotics), are potentially synergistic with antibiotics and have been shown to restore antibiotic sensitivity to drug-resistant bacteria.