Nasdaq: CFRX

Product Candidates

The next generation of anti-infectives.

We intend to develop and commercialize novel, first-in-class biologic therapies, known as direct lytic agents (DLAs), as a potential new medical modality to treat severe, life-threatening infections.  These infections are often caused by antibiotic-resistant, MDR, or XDR pathogens. The increasing prevalence of antibiotic resistance has been widely recognized as an urgent public health threat by the CDC, the WHO, the Infectious Disease Society of America, the Gates Foundation and the Wellcome Trust.

Our lead lysin, exebacase (CF-301) is an investigational product candidate that targets S. aureus, including MRSA strains, which causes serious infections such as bacteremia and pneumonia, and coagulase-negative Staph (CoNS), such as S. epidermidis, which causes debilitating prosthetic joint infections (PJI).

We expect to initiate dosing of intra-articular exebacase in a Phase 1b/2 clinical study in patients with chronic prosthetic joint infections (PJI) of the knee due to S. aureus or CoNS. Exebacase has been studied in Phase 2 and Phase 3 clinical trials in patients with complicated S. aureus bacteremia, including right-sided endocarditis. Further development for this indication will be based on additional, relevant clinical data in the future or through partnership opportunities.

We expect to submit an IND for CF-370, an engineered lysin therapeutic candidate, with potent activity against P. aeruginosa, A. baumannii, and K. pneumoniae.  We believe CF-370 represents the first lysin to bypass the outer membrane of Gram-negative bacteria and to demonstrate potent activity in human serum. Potential development of CF-370 as a broad-spectrum agent for use in pulmonary exacerbations in Cystic Fibrosis patients, HAP/VAP, cUTIs, cIAIs, burn/wound infections, catheter-related infections, and bacteremia is based on extensive in vitro characterization and demonstrated efficacy in animal models of infection.

Our research efforts remain focused on a broad-based Gram-negative discovery program which aims to identify and optimize DLAs that target deadly Gram-negative pathogens, including those that could be weaponized. We have discovered lead compounds with potent activity against B. cepacia, Y. pestis and S. marcescens.  These DLAs have the potential to be developed as BioDefense agents to secure the U.S. population against certain biological threats.