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ContraFect begins Phase I trial of CF-301 for staph bloodstream infections

ContraFect, a biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases, has commenced screening of healthy volunteers in its Phase 1 clinical trial of CF-301.

CF-301 is being developed to be used in combination with standard of care antibiotics for the treatment of Staph bloodstream infections, including infective endocarditis, caused by drug-sensitive and drug-resistant Staph aureus.

"ContraFect is pleased to announce this significant milestone for the Company and CF-301, our novel anti-Staph compound that has the potential to disrupt the treatment paradigm for drug-sensitive and drug-resistant Staph infections, including the MRSA superbug," said Julia P. Gregory, ContraFect’s chief executive officer.

"Our corporate mission is to bring much needed therapies to patients to help solve the world crisis associated with increasing drug-resistance. Advancing CF-301 into clinical development is an important first step."

ContraFect will be conducting a single Phase 1 randomized, double-blind, placebo-controlled, dose-ranging trial in healthy volunteers in the United States to evaluate the safety, tolerability and pharmacokinetics of CF-301 alone in healthy volunteers.

A data safety monitoring board will review the safety and pharmacokinetic data for each dose level and inform the company of its ability to proceed to the next higher dose. Additional information on the trial can be found at www.clinicaltrials.gov.

CF-301 is a bacteriophage lysin with potent activity against Staph aureus infections. CF-301 has the potential to be a first-in-class treatment for Staph bacteremia as it has a new mechanism of action for eliminating bacteria.

It has specific and rapid bactericidal activity against Staph aureus and does not impact the body’s good bacteria. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to CF-301. In vitro and in vivo experiments have shown that CF-301 clears biofilm.

Combinations of CF-301 with standard of care antibiotics increased survival significantly in animal models of disease when compared to treatment with antibiotics or CF-301 alone. CF-301 was licensed from The Rockefeller University and developed at ContraFect.