AmpliPhi Biosciences Corporation, a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, today announced 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
"Pseudomonas aeruginosa is not only a challenging infection to treat, but one that represents a serious threat to the cystic fibrosis community as well as to lung transplant patients," said Saima Aslam, M.D., Director, Solid Organ Transplant Infectious Diseases, University of California San Diego School of Medicine. "Having been involved in cases that have used emergency INDs to treat patients with investigational bacteriophage therapy, I welcome today's news, as it has the potential to bring more widespread use of this treatment to the critically ill patients who could benefit from it."