Overview

To view our CMO present an overview of the CF-301 program at the Duke-Margolis Center for Health Policy Forum on Emerging Non-Traditional Antibiotics, please click on the link below:

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CF-301 (exebacase) is a bacteriophage-derived lysin with potent activity against Staphylococcus aureus ("Staph aureus"). CF-301 is the first and only lysin to enter human clinical trials in the US. This compound is being studied in a Phase 2 clinical trial for the treatment of Staph aureus bloodstream infections (BSI; bacteremia), including endocarditis, caused by methicillin-resistant and susceptible Staph aureus (MRSA and MSSA) strains. New drug-resistant strains of Staph aureus have been identified which demonstrate resistance against vancomycin and daptomycin, the only two standard-of-care (SOC) antibiotics indicated for the treatment of MRSA BSI in the US. CF-301 has the potential to be a first-in-class, new treatment for Staph aureus bacteremia. CF-301 has specific and rapid bactericidal activity against Staph aureus. The addition of CF-301 to either vancomycin or daptomycin increased survival significantly in animal models of disease when compared to treatment with SOC antibiotics or CF-301 alone. CF-301 targets a highly conserved region of the cell wall that is vital to bacteria, thus making resistance less likely to develop. When used in combination with SOC antibiotics, the result is a novel combination therapy that has the potential to combat the high unmet clinical need of Staph aureus infections.

Advantages

  • Rapidly clears biofilms
  • Demonstrated cidality at least 12x faster than SOC antibiotics (in vitro)
  • Specifically targets Staph aureus
  • Administration in addition to SOC antibiotics offers a superior treatment approach based on animal models

CF-301 vs. Biofilms

Biofilms act as armor for bacteria by coating their surface and preventing antibiotics from killing them. Biofilms are produced by pathogenic bacteria and can be formed on heart valves, catheters and prosthetic devices. Biofilms also contain bacterial cells which are dormant, and therefore aren't affected by antibiotics that require bacterial metabolism for their activity. Treatment of biofilm infections can take months of intense antibiotic therapy, and often the only "cure" for a biofilm infection is surgical removal of the material on which it forms, such as the removal of an infected catheter or even the removal of an infected pacemaker, hip or knee. There are currently no products indicated for the treatment of biofilms. CF-301 has demonstrated anti-biofilm activity in vitro and in an explanted human catheter.

CF-301: Biofilm Removal from Catheter Surface

Eradicate 1

MRSA biofilm infected catheter

Eradicate 2

CF-301: 30 Seconds: Biofilm eradicated

Eradicate 1

CF-301: 15 Minutes: Catheter sterilized

Market Need

Staph aureus bloodstream infections occur in both hospital and community settings, causing an estimated 200,000 hospitalizations each year in the U.S. with mortality rates over 20%. Drug-resistant strains of Staph aureus such as MRSA have now been reported to exhibit resistance to SOC antibiotics (e.g. vancomycin and daptomycin). New agents are necessary to address this emerging threat, which may ultimately result in infections for which no available therapies are effective. CF-301 has the potential to address this therapeutic need as it acts by a unique mechanism that has exhibited microbiologic activity against all strains of Staph aureus, including resistant strains, in in vitro experiments.

200,000

Annual Cases of Staph Bacteremia In the U.S.

20%+

Cases in the U.S. That Result in Death

Clinical Summary

CF-301 is the first bacteriophage-derived lysin to enter clinical development in the US. The clinical development program will investigate CF-301 in combination with approved anti-staphylococcal agents for the treatment of Staph aureus bloodstream infections, including endocarditis.

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