First-in-Class Anti-Infective Agent Granted Fast Track Status for Severe CABP

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to CAL02 for the treatment of severe community-acquired bacterial pneumonia (SCABP) as an add-on therapy to standard of care.

CAL02 is a first-in-class non-biological, broad-spectrum, bacterial virulence neutralizer. The investigational treatment consists of proprietary, engineered liposomes that capture and neutralize bacterial toxins known to dysregulate inflammation, cause organ damage, and impede immune defense. 

The designation is supported by data from a phase 1 trial (ClinicalTrials.gov Identifier: NCT02583373), which showed a promising efficacy, safety, and tolerability profile for CAL02 in patients with SCABP. The Company is evaluating the efficacy and safety of CAL02 in addition to standard of care in patients with SCABP in an ongoing phase 2 trial (ClinicalTrials.gov Identifier: NCT05776004).

“CAL02 would serve as an add-on to standard of care antibiotic therapy for the prompt treatment of severe bacterial pneumonia and its devastating consequences,” said Scott Tarriff, President and CEO of Eagle Pharmaceuticals. “In an era of increasing resistance to standard therapies, CAL02 represents a potential resistance-free empiric therapy to protect organs and prevent pro-inflammatory cascades leading to severe and fatal outcomes.”