FDA gives Eagle Pharmaceuticals Qualified Infectious Disease Product (QIDP) and Fast-Track Designation for SCABP drug
US-based pharmaceutical company Eagle Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted its severe community-acquired bacterial pneumonia (SCABP) drug Qualified Infectious Disease Product (QIDP) status under the Generating Antibiotic Incentives Now (GAIN) Act, and Fast-Track Designation.
CAL02 is a non-biological bacterial virulence neutraliser, anti-infective agent whose liposomes are engineered to act as a lure for bacterial virulence factors produced by a range of Gram-positive and Gram-negative bacteria. These factors contribute to infection-related complications, sepsis, septic shock and death. The drug aims to play a key role in the fight against anti-microbial resistance, as its action is complementary to antibiotics – however, it does not appear to use selective pressure, which can contribute to antibiotic resistance.
The drug is currently being tested in a phase 2, adaptive, randomised, double-blind, placebo-controlled study which is designed to assess the efficacy and safety of CAL02 as an intravenously-administered treatment in addition to standard of care in patients with SCABP. Approximately 276 patients worldwide are planned to be enrolled.
Scott Tarriff, president and CEO of Eagle Pharmaceuticals, stated: “Receiving QIDP designation underscores the importance of CAL02 for potentially treating SCABP, and the Fast Track Designation allows us to work even closer with the FDA to bring patients a new treatment option sooner as we would also be eligible to request Priority Review for our application. Antibiotics alone, unfortunately, cannot win the war against pneumonia. 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. 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. This treatment could represent a true paradigm shift and offer healthcare providers another option in combating this complex disease. Eagle believes that CAL02 is the first potential therapy engineered to neutralise a broad range of bacterial toxins for SCABP to receive QIDP designation, and we look forward to providing updates as CAL02 advances through the clinical programme.”
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