YPT-01 / Felix Biotech - LARVOL DELTA

Cystic Fibrosis Bacteriophage Study at Yale (CYPHY) (ATS 2024) - "The study drug was Yale Phage Therapy 01 (YPT-01), a nebulized single phage therapy determined for each subject by an algorithm that selects the best performing phage from three candidate phages depending on baseline susceptibility testing... MDR P. aeruginosa is increasingly common and exceedingly difficult to manage. Therefore, development of novel therapeutic approaches that reduce infection with minimal side-effects, are highly desirable. In this first in human inhaled phage therapy clinical trial there was no difference in bacterial titers, but inhaled phage therapy was shown to be safe."

Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

CYstic Fibrosis bacterioPHage Study at Yale (CYPHY) (clinicaltrials.gov) - P1/2 | N=8 | Completed | Sponsor: Yale University | Active, not recruiting ➔ Completed | Trial completion date: Mar 2023 ➔ Jun 2023 | Trial primary completion date: Sep 2022 ➔ May 2023

Trial completion • Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Cystic Fibrosis bacterioPHage study at Yale (CYPHY) (NACFC 2023) - "The study drug was Yale Phage Therapy 01 (YPT-01), a nebulized single-phage therapy determined for each subject using an algorithm that selects the best-performing phage from among three candidate phages depending on baseline susceptibility testing... MDR P. aeruginosa is increasingly common in CF and exceedingly difficult to manage. Therefore, development of novel thera-peutic approaches that reduce infection with minimal side-effects are highly desirable to the CF community. In this first-in-human inhaled phage–therapy clinical trial, there was no difference in bacterial titers, but inhaled phage therapy was shown to be safe."

Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

CYstic Fibrosis bacterioPHage Study at Yale (CYPHY) (clinicaltrials.gov) - P1/2 | N=8 | Active, not recruiting | Sponsor: Yale University | Recruiting ➔ Active, not recruiting | N=36 ➔ 8 | Trial primary completion date: Dec 2022 ➔ Sep 2022

Enrollment change • Enrollment closed • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

CYstic Fibrosis bacterioPHage Study at Yale (CYPHY) (clinicaltrials.gov) - P1/2 | N=36 | Recruiting | Sponsor: Yale University | Trial completion date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Sep 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

CYstic Fibrosis bacterioPHage Study at Yale (CYPHY) (clinicaltrials.gov) - P1/2; N=36; Recruiting; Sponsor: Yale University; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Sep 2021 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

CYstic Fibrosis bacterioPHage Study at Yale (CYPHY) (clinicaltrials.gov) - P1/2; N=36; Recruiting; Sponsor: Yale University; Not yet recruiting ➔ Recruiting

Enrollment open • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Felix Biotechnology announces initiation of the CYPHY Phase 1/2 study at Yale for its lead asset targeting P. aeruginosa infections (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....'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.'"

Trial status • Cystic Fibrosis • Infectious Disease