Bacteriophage Company Reports Success With Expanded Access Program For Resistant Infections

AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, today announced updated topline clinical results for its ongoing single-patient expanded access program. 84% of patients achieved treatment success (physician’s assessment) at the end of therapy, defined as complete resolution or significant improvement of baseline signs and symptoms.

AmpliPhi has now provided its investigational bacteriophage therapeutics for a total of 21 patients, at 7 hospitals, with serious or life-threatening infections not responding to antibiotic therapy. These patients were treated with AB-SA01 or AB-PA01 under single-patient expanded access programs in the U.S. (Emergency INDs per the U.S. Food and Drug Administration) or Australia (Special Access Scheme per the Australian Therapeutic Goods Administration). The following analysis updates the data previously announced by the company on January 3, 2018:

15 patients with serious S. aureus infections were treated with AB-SA01 and 6 patients with serious P. aeruginosainfections were treated with AB-PA01.
Infections in the treated patients included bacteremia, native and prosthetic valve endocarditis, recurrent pneumonia, ventilator-associated pneumonia, prosthetic joint infection, ventricular assist device infection, and others.

• Over 1,000 bacteriophage doses were administered as part of the expanded access program including:
• 400+ doses of AB-SA01, including 300+ doses administered intravenously. Treatment was well-tolerated in all patients with no treatment related serious adverse events (SAEs).
• 600+ doses of AB-PA01, including 400+ doses administered intravenously. Treatment was well-tolerated in five patients. One patient discontinued treatment due to Grade 1 and 2 adverse events, which resolved within 18 hours. There were no treatment-related SAEs.
• 84% (16 out of 19) of patients in the modified intent-to-treat population (mITT) 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. mITT population was defined as all patients who met the criteria for clinical diagnosis, whose bacterial isolate was susceptible to phage and who received at least one dose of phage.

“The encouraging results from AmpliPhi’s expanded access program support the view that phage therapeutics can be safely administered and provide anecdotal evidence of their efficacy, which we hope to soon demonstrate in randomized, controlled clinical trials,” said Dr. 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. “I look forward to helping bring this potentially important new modality to seriously ill patients, including those in whom usual treatment options are commonly inadequate.”

AmpliPhi Biosciences Corporation is a clinical-stage biotechnology company focused on treating antibiotic-resistant infections using its proprietary bacteriophage-based technology. AmpliPhi’s lead clinical stage product candidates, AB-SA01 and AB-PA01, target multidrug-resistant Staphylococcus 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.

AmpliPhi currently has two products available via its expanded access program. AB-SA01 targets S.aureas and AB-PA01 targets P.aeruginosa.

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