- Company received positive written response from FDA regarding development plans
- Resistant P. aeruginosa is designated as ‘Priority 1: Critical’ pathogen by the World Health Organization
AmpliPhi Biosciences Corporation (NYSE American: APHB) announced on 9/18/18 that the company has received positive feedback, via written response, from the U.S. Food and Drug Administration (FDA) regarding its development plans for AB-PA01, without the need for a Type B Pre-IND meeting.
“We are delighted with the FDA’s response to our development plans for AB-PA01, AmpliPhi’s bacteriophage product candidate targeting Pseudomonas aeruginosa infections, and the FDA’s concurrence on the proposed design of two randomized controlled clinical trials, in hospital-acquired and ventilator-associated pneumonia and P. aeruginosa bacteremia,” said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. “Resistant P. aeruginosa is designated as ‘Priority 1: Critical’ pathogen on the World Health Organization’s Priority Pathogens List and as ‘Serious Threat’ by the U.S. Centers for Disease Control and Prevention.”
“Additionally, I am strongly encouraged to see the FDA’s dedication to addressing the challenges of antimicrobial resistance and promoting the development of new products, including bacteriophage therapeutics, as stated by the FDA’s Commissioner, Scott Gottlieb, at the unveiling of the FDA’s 2019 Strategic Approach for Combating AMR on September 14, 2018.”
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 randomized, 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 the following two proposed randomized clinical trials:
- 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 to Pseudomonas aeruginosa
- 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 reported success with it's expanded access program on 9/17/18.
AmpliPhi currently has two products available via its expanded access program. AB-SA01 targets S.aureas and AB-PA01 targets P.aeruginosa.
You can learn more about bacteriophages here.