BARDA is partnering with ContraFect Corporation to develop exebacase for the treatment of Staphylococcus aureus bacteremia, including methicillin-resistant Staphylococcus aureus (MRSA), a secondary bacterial infection that complicates responses to public health emergencies as well as common medical practices, and is a major cause of sepsis.
Exebacase is the first product candidate in a new family of protein-based antimicrobials known as direct lytic agents (DLAs). DLAs present a potential new medical modality for the treatment of life-threatening, antibiotic-resistant infections. DLAs, like exebacase, catalyze the destruction of the bacterial cell wall, resulting in rapid, targeted bacteriolysis. This unique activity makes it difficult for bacteria to develop resistance to exebacase. Exebacase also has the potential to eradicate biofilms, which can complicate medical treatment. Exebacase has been granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA).
S. aureus remains a major health challenge and is associated with mortality rates of 20-40 percent. MRSA, in particular, continues to be the leading cause of hospital-acquired infections and bacterial sepsis in the U.S. and ranks as a serious threat on the 2019 CDC Antibiotic Resistance Threat list. This pathogen is often an opportunistic, secondary infection that occurs as a consequence of a breakdown in infection control practices such as those observed during the COVID-19 pandemic. If successful, exebacase could significantly improve clinical outcomes when used in addition to standard of care antibiotics against S. aureus bacteremia (SAB), including MRSA.
This partnership will support Phase 3 clinical development and the submission of a Biologics License Application (BLA) to the FDA, as well as post-approval activities including a pediatric study and a lyophilized drug product formulation to facilitate long-term storage.
About ContraFect Corporation:
The following information is provided by company and does not indicate endorsement by the federal government of the company or its products.
ContraFect is a biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections. The company intends to address life threatening infections using our therapeutic product candidates from its platform of DLAs, which include lysins and amurin peptides. Lysins are a new class of DLAs which are recombinantly produced antimicrobial proteins with a novel mechanism of action associated with the rapid killing of target bacteria, eradication of biofilms and synergy with conventional antibiotics. Amurin peptides are a novel class of DLAs which exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, including Pseudomonas aeruginosa (P. aeruginosa), Acinetobacter baumannii, and Enterobacter species.