Exebacase is the first bacteriophage-derived lysin to enter clinical development in the US. The clinical development program will investigate exebacase in addition to approved anti-staphylococcal agents for the treatment of Staph aureus bloodstream infections, including endocarditis.
CF-301 is being studied in a multi-center, multi-national Phase 2 clinical trial for the treatment of Staph aureus bacteremia, including endocarditis, caused by MRSA or MSSA. This randomized, double-blind, placebo-controlled study compares the efficacy, safety and tolerability of CF-301 used in addition to SOC antibiotics to SOC antibiotics alone. The study is expected to enroll 115 patients randomized 3:2 to receive either a single dose of CF-301 administered via 2 hour IV infusion in addition to SOC antibiotics or placebo plus SOC antibiotics. The primary endpoint of the study is early clinical response at Day 14. Clinical response is defined by objective clinical response criteria including survival, reduction/resolution of symptoms, lack of progression of infection and lack of need for additional antistaphylococcal antibiotics, and is adjudicated by an independent clinical adjudication committee of disease area experts. Additional exploratory clinical, microbiologic and health resource utilization endpoints are also being assessed in the trial. More information about this trial can be found at www.clinicaltrials.gov.
A Phase 1 trial of exebacase in healthy volunteers was concluded in December 2015. No clinical adverse safety signals were observed. This study was designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single escalating doses of exebacase administered intravenously to healthy volunteers.