ContraFect Presents New CF-301 Data at ASM Microbe 2016
YONKERS, NY -- (Marketwired) -- 06/21/16 -- ContraFect Corporation (NASDAQ: CFRX) (NASDAQ: CFRXW) , a biotechnology company focused on the discovery and development of protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, today provides details of new data presented at the ASM Microbe 2016 Conference (ASM 2016), which was held June 16-20, 2016 in Boston, MA.
ContraFect scientists presented new data at ASM 2016, which advance the understanding of the projected efficacious human dose and microbiologic profile of CF-301, which is currently in development for the treatment of Staphylococcus aureus (Staph aureus) bloodstream infections, including MRSA. Presentations included a Late Breaker poster presentation on the pharmacokinetics-pharmacodynamics (PK-PD) drivers of efficacy of CF-301, and two oral presentations of new microbiologic data: one showing the lack of CF-301 resistance development among Staph aureus strains exposed to CF-301, and the other describing the post-antibiotic effect of CF-301.
Late Breaker Poster Presentation: "PK-PD Driver of Efficacy for CF-301, a Novel Anti-Staphylococcal Lysin: Implications for Human Target Dose"
- PK-PD modeling of data from animal models and human clinical studies is a well-established methodology to determine the target human blood levels and human dosing of antibacterial agents.
- Standard mouse infection model studies to determine the optimal dosing regimen of CF-301 for maximal bacterial killing were conducted using ten strains of Staph aureus isolated from human infections. Additional experiments using CF-301 in combination with antibiotics were also performed.
- Target efficacious blood levels were determined from these animal studies and combined with human population PK analyses conducted using blood levels of CF-301 measured in the Phase 1 study of CF-301 (to be presented elsewhere) to determine the doses of CF-301 expected to be efficacious in humans.
- Human doses of ≥0.25 mg/kg were projected to exceed the target level required for maximal killing when combined with standard of care agents, supporting the choice of a 0.25 mg/kg dose which has been selected for use in an upcoming Phase 2 clinical trial.
Oral Presentation: "Staphylococcus aureus Resistance to Lysin CF-301 Does Not Arise in Human Serum"
- Serial passage studies are a standard method to determine the propensity of bacteria to form resistance to an antibiotic agent.
- CF-301 was studied in serial passage studies in human serum using Staph aureus strains over a period of 21-26 days, showing that high levels of resistance to CF-301 do not emerge in human serum.
- While exposure of MRSA to CF-301 in the serial passage assays did not result in CF-301 resistance, it did, however, result in increased sensitivity to oxacillin (with corresponding MIC decreases of 16 to 32 fold).
Oral Presentation: "Post-Antibiotic Effects of Lysin CF-301 Against Staphylococcus aureus"
- A post-antibiotic effect (PAE) is a prolonged biologic effect seen after drug levels decline to zero, and may convey additional therapeutic benefit to infected patients beyond the period of drug exposure.
- The PAE of CF-301 was studied in vitro using 14 different Staph aureus strains from human infections both as a monotherapy and in combination with daptomycin. CF-301 was further studied in a model of biofilm formation and a mouse model of infection.
- After exposure to, and removal of CF-301, bacterial growth was suppressed in the in vitro growth, biofilm formation, and mouse infection model, with strong PAEs in all three systems.
- Additional in vitro growth PAE experiments examining combinations of CF-301 with daptomycin indicate synergistic PAE enhancement for the combination, adding to the rationale for combination dosing in the upcoming CF-301 Phase 2 trial.
CF-301 is a recombinant bacteriophage-derived lysin with potent bactericidal activity against Staph aureus, a major cause of blood stream infections, or bacteremia. CF-301 has the potential to be a first-in-class treatment for Staph aureus bacteremia. It has a novel, rapid, and specific mechanism of bactericidal action against Staph aureus and does not impact the body's natural bacterial flora. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to CF-301. Combinations of CF-301 with standard of care antibiotics significantly increased bacterial killing and survival in animal models of disease when compared to treatment with antibiotics or CF-301 alone. In addition, in vitro and in vivo experiments have shown that CF-301 is highly active against biofilm formation. CF-301 was licensed from The Rockefeller University and is being developed at ContraFect.
ContraFect is a biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. An estimated 700,000 deaths worldwide each year are attributed to antimicrobial-resistant infections. We intend to address life threatening infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). ContraFect's initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (Methicillin-resistant Staph aureus) and influenza.
This press release contains, and our officers and representatives may make from time to time, "forward-looking statements" within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar references to future periods. Examples of forward-looking statements include statements made regarding ContraFect's therapeutic product candidate CF-301, including its ability to: treat Staph aureus infections, including MRSA, show lack of resistance development, convey a post-antibiotic effect, be a first-in-class treatment, show increased effectiveness when combined with other antibiotics and show activity against biofilm formation; CF-301 Phase 2 study plans, including dose amount and combination dosing; and in vitro and in vivo study results. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect's current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect's control, including those detailed in ContraFect's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include, among others, our ability to develop treatments for drug-resistant infectious diseases. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
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Source: ContraFect Corporation
Released June 21, 2016