Research & Development
AmpliPhi Biosciences Receives Positive FDA Feedback for its Clinical Stage Bacteriophage Product Candidate AB-PA01 Targeting Pseudomonas Aeruginosa Infections
20 September 2018 - - US-based clinical-stage biotechnology company AmpliPhi Biosciences Corp. (NYSE American: APHB) has received positive feedback, via written response, from the US Food and Drug Administration regarding its development plans for AB-PA01, without the need for a Type B Pre-IND meeting, the company said.

AmpliPhi's engagement with the FDA included an update on the company's ongoing Expanded Access Program, as well as the proposed design for two randomised, controlled clinical trials with AB-PA01, the company's clinical candidate targeting P. aeruginosa.

The FDA was in general agreement with the proposed clinical trial designs and, based on the current FDA feedback, no additional clinical or nonclinical data are required to proceed with two proposed randomised clinical trials.

The first of these would be a Phase 1/2 randomized, controlled clinical trial to evaluate the safety and efficacy of AB-PA01, administered intravenously with the best available antibiotic therapy, compared to placebo plus best available antibiotic therapy, in approximately 100 patients with hospital-acquired and ventilator-associated pneumonia (HAP/VAP) due toPseudomonas aeruginosa.

The second would be a Phase 1/2 randomized, controlled clinical trial to evaluate the safety and efficacy of AB-PA01, administered intravenously with the best available antibiotic therapy, compared to placebo plus best available antibiotic therapy, in approximately 100 patients with P. aeruginosa bacteremia.

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

The company'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.

AmpliPhi received regulatory guidance for the development of its bacteriophage therapy and intends to initiate the first randomised clinical trial for AB-SA01 in early 2019.
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