The US Food and Drug Administration (FDA) has granted Fast Track designation to clinical-stage biotechnology company ContraFect Corporation's CF-301, the first lysin in a new class of medicines, currently in a phase 1 clinical trial, for the treatment of Staph aureus bloodstream infections, including methicillin-resistant Staphylococcus aureus (MRSA).
"ContraFect is pleased that the FDA has granted Fast Track designation to CF-301, and we look forward to the opportunity to interact more frequently with the FDA as we develop a new medicine with the potential to transform the treatment paradigm for drug-resistant Staph aureus bloodstream infections, including the MRSA superbug," said Julia P. Gregory, ContraFect's chief executive officer.
"This designation may also accelerate the availability of CF-301 to patients with these serious, potentially life threatening infections, if the drug successfully completes clinical development."
Established under the FDA Modernization Act of 1997, the Fast Track Drug Development Programme is intended to facilitate the development, as well as expedite the review of drugs to treat serious conditions and potentially fill an unmet medical need. The Fast Track designation provides earlier access to and more frequent communication with the FDA regarding all aspects of a designated drug's clinical development programme. Additionally, the designated drug may be eligible for submission of the New Drug Application (NDA) on a rolling basis as well as accelerated approval and priority review if supported by clinical data at the time of the NDA submission.
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.
Lysins are enzymes that digest the cell wall of bacteria. Once the cell wall is breached, the bacteria is killed on contact. The company believes lysins are unlike standard-of-care antibiotics, especially regarding their mechanism and speed of action. Traditional antibiotics, and most cytotoxic agents, require bacterial cell division and metabolism in order to be effective. Based on in vitro and animal tests, the company believes lysins, however, are fundamentally different in that they have rapid bactericidal activity, target and kill specific bacteria without impacting the good bacteria, eradicate bacteria's protective biofilm, do not have resistance to drug resistant strains and synergize with standard of care antibiotics.