Overview

To view our CMO present an overview of the exebacase 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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Exebacase (CF-301) is a lysin with potent activity against Staphylococcus aureus ("Staph aureus"). Exebacase has the potential to be the first-in-class of a new treatment for patients with Staph aureus bacteremia. The addition of exebacase to either vancomycin or daptomycin increased survival significantly in animal models of disease when compared to treatment with SOC antibiotics or exebacase alone. Exebacase 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 treatment modality that has the potential to combat the high unmet clinical need of Staph aureus infections.

Exebacase is the first and only lysin to enter human clinical trials in the US and recently completed a Phase 2 superiority study evaluating the safety efficacy and tolerability of exebacase in patients with Staph aureus bacteremia, including endocarditis. In particular, the improvement in patient response rates of the pre-specified MRSA population was remarkable across the whole MRSA population (42.8% improvement; p=.010) as well as MRSA subgroups – by SOC antibiotic, source of infection or complicated bacteremia – establishes the basis on which exebacase will be studied in Phase 3.

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

Exebacase 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. Exebacase has demonstrated anti-biofilm activity in vitro and in an explanted human catheter.

Exebacase: 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. Exebacase has the potential to address this therapeutic need as demonstrated by its in vitro and in vivo microbiologic activity against MRSA and the Phase 2 clinical data.

200,000

Annual Cases of Staph Bacteremia In the U.S.

20%+

Cases in the U.S. That Result in Death

Clinical Summary

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.

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Gram-negative lysins

We have discovered and engineered lysins which target and kill Gram-negative pathogens, including multi-drug resistant strains.

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Amurins

We have discovered a new class of direct lytic agents, antimicrobial peptides, that have potent in vitro activity across a wide range of resistant Gram-negative pathogens.

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