According to Felix Biotechnology, Yale University researchers have initiated a Phase 1/2 trial of Felix’s YPT-01 nebulized phage therapy for the treatment of chronic P. aeruginosa infections in cystic fibrosis patients. YPT-01 was initially formulated at Yale and licensed to Felix, a start-up founded by Yale Faculty. Felix recently signed a deal with TFF Pharmaceuticals for development of a dry powder phage formulation.
The CYPHY study is expected to enroll 36 CF patients who will receive one of two doses of YPT-01 or placebo in addition to standard therapy. A grant from the Cystic Fibrosis Foundation is providing funding for the trial.
Felix notes that 12 patients have already been treated with YPT-01 under emergency INDs. During Digital RDD 2020, Yale researcher Ben Chan gave a talk on his work with the inhaled phage therapy and presented several case studies of patients with drug-resistant P. aeruginosa lung infections who were re-sensitized to antibiotics following phage treatment.
Felix Biotechnology Co-Founder and Yale Professor of Ecology and Evolutionary Biology Paul Turner commented, “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. 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.”
CEO Rob McBride said, “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. 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.”
Read the Felix Biotechnology press release.
