- 10 of 12 patients achieved treatment success
- AB-SA01 was well tolerated with no adverse events attributable to AB-SA01
- Initial gene expression data indicate that bacteriophage treatment may downregulate pro-inflammatory genes and upregulate anti-inflammatory genes
- AmpliPhi currently has two products in development
AmpliPhi Biosciences Corporation (NYSE American:APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, today announced the presentation of clinical case series data from the company’s ongoing expanded access program for its investigational bacteriophage therapeutic, AB-SA01 targeting Staphylococcus aureus (S. aureus), at the IDWeek 2018 conference in San Francisco.
Prof. Jonathan Iredell, Senior Staff Infectious Diseases Physician at the Westmead Hospital in Sydney, Director of Centre for Infectious Diseases and Microbiology at the Westmead Institute of Medical Research and Professor of Medicine and Microbiology at the University of Sydney, gave a presentation “Adjunctive bacteriophage therapy for severe Staphylococcal sepsis,” including data on 13 patients suffering from severe S. aureus infections, who were treated with AB-SA01 as an adjunct to antibiotics at the Westmead Hospital in 2017-2018. The potential treatment of S. aureus bacteremia with AB-SA01 was also the subject of the Company’s recent Type B meeting with the FDA. The treatment was conducted under emergency protocols per the Australian Therapeutic Goods Administration’s (TGA) Special Access Scheme (SAS).
Highlights from the presentation include the following:
- 13 patients treated with AB-SA01 had severe S. aureus sepsis and/or bacteremia. The patients had not responded to prior conventional antibiotic therapy and were eligible for treatment with AB-SA01 under the Australian TGA SAS Category A, which allows therapy for a patient who is “seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.”
- 10 of the patients also suffered from infective endocarditis (infection of the endocardium, the inner lining of the heart chambers and heart valves), and 5 of these patients had prosthetic valve endocarditis, which can be particularly challenging to treat with antibiotics due to formation of bacterial biofilm.
- Approximately 290 doses of AB-SA01 were administered intravenously and were well tolerated with no adverse events attributable to AB-SA01.
- 83% of patients (10 out of 12) in the mITT population achieved treatment success at the end of therapy. Treatment success, as determined by the treating physician, was defined as a complete resolution or significant improvement of baseline signs and symptoms.
- Initial gene expression data indicate that bacteriophage treatment may downregulate pro-inflammatory genes and upregulate anti-inflammatory genes, which could be important for treatment of patients with sepsis to prevent septic shock and for patients with endocarditis to prevent destruction of heart tissue.
AmpliPhi currently has two products in development. AB-SA01 is being developed for S. aureus and AB-PA01 is being developed for P. aeruginosa.
To learn more about bacterphage therapy check out our primer on bacteriophages here.