SAN FRANCISCO, Jan. 7, 2021 /PRNewswire/ -- Felix Biotechnology today announced the initiation of CYPHY, a Phase 1/2 investigator-initiated single center trial at Yale University for targeted phage therapy YPT-01 in the treatment of chronic P. aeruginosa infections in cystic fibrosis. This double-blind, placebo-controlled study (NCT 04684641) will assess the safety and efficacy of YPT-01 added to standard antimicrobial therapy in 36 patients. CYPHY will also assess the ability of YPT-01 to reduce the virulence and antibiotic-resistance of P. aeruginosa, improving patient outcomes and re-enabling use of traditional antibiotics against multi-drug resistant strains. The lead investigator for this study, Dr. Jon Koff, Associate Professor and Director of Yale's Adult Cystic Fibrosis Program, is supported by an academic grant from the Cystic Fibrosis Foundation.
"This is a fantastic opportunity to show how effective phage therapy can be when deployed in an evolutionary framework. We know that pathogens evolve resistance to any antibiotic or therapy we use, so our approach turns that to our advantage," said Dr. Paul Turner, Professor of Ecology and Evolutionary Biology, co-inventor of YPT-01, and co-founder of Felix Biotechnology. "By targeting phage to mechanisms of virulence, we ensure that if pathogens evolve resistance to phage, they lose traits that make them effective pathogens, putting them in an evolutionary Catch-22."
"Phage therapies have been used for over a century but for various reasons clinical trials to demonstrate their efficacy have been unsuccessful. In designing CYPHY, we learned from those studies to develop best practices for a truly blinded, randomized, placebo-controlled phage therapy trial. But most importantly, this study aims to help patients," said Dr. Ben Chan, Research Scientist and co-inventor of YPT-01.
YPT-01 is an inhaled phage therapy that targets and kills P. aeruginosa and has been administered to 12 patients with chronic and multi-drug resistant infections via emergency INDs. The phages comprising YPT-01 were selected based on safety, efficacy against clinical isolates of P. aeruginosa, and unique abilities to reduce virulence and antibiotic resistance. This evolutionary biology approach benefits patients and physicians by effectively treating infections, reducing the threat of subsequent infections, and ensuring a treatment option is always available. It may also benefit healthcare systems and public health overall by driving reductions in virulence and antibiotic resistance in hospital pathogen populations, counteracting decades of selection by traditional antibiotics.
Felix Biotechnology holds an exclusive license from Yale for YPT-01. "Our key focus at Felix Biotechnology is to help patients and we are very excited to see this therapy move into a 36 patient controlled and blinded trial," said Rob McBride, Felix Biotechnology's CEO. "If the data from this trial reflect earlier human data showing safety and efficacy, we will focus on moving this asset into a larger commercial trial as soon as possible."
YPT-01 is an inhaled phage therapy that targets and kills P. aeruginosa and has been administered to 12 patients with chronic and multi-drug resistant infections via emergency INDs. The phages comprising YPT-01 kill P. aeruginosa and drive trade-offs in virulence and antibiotic resistance in any residual pathogen, reducing pathogen threat and improving patient outcomes.
About Felix Biotechnology
Felix Biotechnology is a clinical stage biotherapeutics company focused on helping patients who can't wait by developing and deploying non-traditional antibiotics targeting urgent microbial threats. Felix's engineering and discovery platforms, built on technology from Yale University and UC Berkeley, generate therapies that overcome the key limitations of traditional phage therapy to develop generalized solutions that kill targeted bacterial infections while preserving healthy microbiome function. Felix is a seed stage company funded by multiple investors, including Y Combinator, Illumina Accelerator and Point72 Ventures.