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Home Research & Development News AmpliPhi Biosciences reports favorable final results from Phase I trial of AB-SA01 in CRS patients
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19 Dec 2016

AmpliPhi Biosciences reports favorable final results from Phase I trial of AB-SA01 in CRS patients

AB-SA01 meets primary endpoints of safety and tolerability and reduces S. aureus bacterial load in all patients.

AmpliPhi Biosciences has reported final results from its Phase I trial of AB-SA01, a proprietary investigational bacteriophage (phage) cocktail targeting Staphylococcus aureus (S. aureus) infections, in patients with chronic rhinosinusitis (CRS). AB-SA01 met the trial’s primary endpoints of safety and tolerability and all nine patients enrolled in the study experienced a reduction in the quantity of S. aureus infecting their sinuses, with some patients showing complete eradication of the bacterial infection.

Key findings from the study include

  • Primary endpoints of safety and tolerability were met

  • All patients experienced a reduction in S. aureus bacterial load at the end of the study compared to baseline

  • Comparison of pre- and post-treatment endoscopic images showed symptomatic improvement, including reductions in mucosal edema, discharge and polyps

  • All enrolled patients completed the trial.

    • “We are delighted with the final results of this trial and are particularly encouraged that we saw a decrease in S. aureus bacterial load in all patients treated with AB-SA01,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “The fact that the patients enrolled in this study had all failed standard of care treatment, including previous sinus surgery, combined with compelling preclinical results in an animal model of CRS and these positive Phase I findings, gives us tremendous confidence in our decision to advance AB-SA01 into a Phase II trial in 2017.”

    The Phase I clinical trial in patients with CRS was initiated in January 2016 and was conducted at the Queen Elizabeth Hospital in Adelaide, Australia in collaboration with the University of Adelaide and Flinders University. All nine patients enrolled received AB-SA01 in one of three dose regimens: Cohort 1 patients received low-dose twice daily for 7 days; Cohort 2 patients received low-dose twice daily for 14 days; and Cohort 3 patients received high-dose twice daily for 14 days.

    Detailed results from the Phase I trial of AB-SA01 in CRS patients will be presented by Dr Mian Ooi, of the University of Adelaide and The Queen Elizabeth Hospital’s department of Otolaryngology, Head and Neck Surgery, at an upcoming medical conference in 2017.

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