FDA grants QIDP and fast track designations for Eagle’s CAL02

The US Food and Drug Administration (FDA) has granted qualified infectious disease product (QIDP) and fast track designations for Eagle Pharmaceuticals’ CAL02.

The QIDP designation has been granted under the Generating Antibiotic Incentives Now (GAIN) Act.

Eagle expects to obtain eight to ten years of regulatory exclusivity for the therapy with QIDP, upon receipt of its new drug application approval.

CAL02 is an investigational, innovative, first-in-class anti-infective agent being developed as an add-on therapy to standard of care in the treatment of severe community-acquired bacterial pneumonia (SCABP).

It acts as a competitive decoy for bacterial virulence factors that contribute to complications, sepsis, septic shock and death following infection.

The therapy comprises liposomes engineered to capture the virulence factors, which are produced by a wide range of Gram-positive and Gram-negative bacteria.

Eagle Pharmaceuticals CEO and president Scott Tarriff stated: “Receiving QIDP designation underscores the importance of CAL02 for potentially treating SCABP, and the fast track designation allows us to work even more closely 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.”

CAL02 currently holds a US patent, which extends protection until September 2035.

It is expected to be eligible for up to five years of patent term extension until 2040.

The company is currently evaluating CAL02 in a Phase II clinical trial, which is expected to enrol 276 SCABP patients globally.

The double-blind, adaptive, randomised, placebo-controlled trial has been designed to evaluate the safety and efficacy of CAL02 given intravenously as an add-on therapy to standard of care in SCABP patients.