ContraFect Corporation (Nasdaq:CFRX), a clinical-stage biotechnology company focused on the discovery and development of protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, today announced that it has completed enrollment in the Phase 2 clinical trial evaluating its first-in-class lysin, CF-301, as a potential treatment for Staphylococcus aureus (Staph aureus) bacteremia including endocarditis.
"We are very pleased to have completed enrollment of this Phase 2 superiority study, which is a major milestone in the development of exebacase (CF-301) as a potential new treatment option for patients with Staph aureus bacteremia including endocarditis. We thank the investigators, study sites and patients for their ongoing participation,” said Cara Cassino, M.D., Chief Medical Officer and Executive Vice President of Research and Development at ContraFect. "Staph aureus bacteremia and endocarditis continue to be associated with substantial morbidity and mortality despite conventional antibiotics. We look forward to the topline results of the Phase 2 study later this year, which will inform us of the potential for CF-301 to improve clinical outcomes for these serious, potentially life threatening Staph aureus infections.”
The multi-center, multi-national, randomized, double-blind, placebo-controlled Phase 2 superiority study is intended to evaluate the potential for CF-301, used in addition to standard-of-care (SOC) antibiotics, to improve clinical cure rates compared to SOC antibiotics alone. The study is ongoing at investigational sites in the United States, Europe, Latin America, Russia and Israel. Approximately 115 patients were planned to be randomized 3:2 to receive either a single dose of CF-301 or placebo administered via intravenous infusion in addition to SOC anti-staphylococcal antibiotics. The primary objectives of the study are to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CF-301.
More information about the study is available at www.clinicaltrials.gov.
About Staphylococcus aureus bacteremia
In the U.S. alone, there are approximately 200,000 hospitalizations for Staph aureus bacteremia annually. Mortality rates from this bloodstream infection have been reported as ranging from 20-40% despite conventional antibiotics. Staph aureus bacteremia may lead to infectious endocarditis, a serious infection affecting the heart valves. The incidence of infective endocarditis in the U.S. has increased over the past decade and is likely due to the growth of the at-risk populations, such as older, diabetic and hemodialysis patients. Staph aureus endocarditis remains difficult to treat with current standard of care antibiotics. One reason for this is biofilm formation which prevents antibiotics from eradicating the bacteria, leading to the need for long courses of antibiotic therapy, which are often unsuccessful and necessitate surgery to eradicate bacteria from infected heart valves. Emerging resistance to conventional antibiotics such as vancomycin and daptomycin represents an additional serious threat which may have serious consequences in terms of increasing morbidity, mortality and health care utilization.
About exebacase (CF-301)
Exebacase (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 infections. CF-301 was licensed from The Rockefeller University and is being developed at ContraFect. It is the first lysin to enter clinical studies in the U.S.