Receiving QIDP Designation underscores the importance of CAL02 to treat severe infections such as severe pneumonia. This is unprecedented for an innovative drug that neutralizes a broad range of bacterial toxins.
The Fast Track Designation allows our partner, Eagle Pharmaceuticals, to work closer with the FDA to bring this novel treatment option sooner to patients. Combioxin granted an exclusive license to Eagle in 2021, and Eagle is currently running a worldwide adaptive Phase 2 study with CAL02 in severe pneumonia patients (Identifier: NCT05776004).
CAL02 is first-in-class virulence neutralizer. This agent brings a true paradigm shift. It represents a potential resistance-free empiric therapy to protect organs and prevent pro-inflammatory cascades leading to severe and fatal outcomes. Initial clinical results were published in The Lancet Infectious Diseases, with an Editorial characterizing the study results as a “medical breakthrough.”
Eagle PR available here