Eagle Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation under the Generating Antibiotic Incentives Now (GAIN) Act and Fast Track Designation for CAL02, a first-in-class non-biological bacterial virulence neutralizer, anti-infective agent being developed to treat severe community-acquired bacterial pneumonia (SCABP) as an add-on therapy to standard of care.

“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,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. “Eagle believes that CAL02 is the first potential therapy engineered to neutralize 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 program.”

The QIDP designation was created by the GAIN Act implemented in 2012 to encourage the development of treatments for antibiotic-resistant organisms known to cause serious or life-threatening infections. Eagle believes that CAL02 could also be eligible for breakthrough therapy designation. Eagle is also further developing the patent estate to protect the intellectual property resulting from the development of this novel, first-in-class therapy. CAL02 is currently protected by issued U.S. Patent No.10,744,089, which extends until September 2035, and may be eligible for Patent Term Extension for up to five years until 2040. CAL02 is also protected by granted counterparts in important markets globally, e.g., Europe and Japan. In addition, CAL02 and its uses are the subject of pending patent families as reflected in published applications WO2017216282, WO2018158375, WO2019201937, WO2019202101, US2023/0028179, US2021/0275452, US2021/0030677, US2021/0259967, and other families under development. These families would provide patent term until approximately 2037 or later.

SCABP is a worldwide prevalent infectious disease associated with high morbidity and mortality, despite the availability of vaccines, effective antibiotic regimens, and state-of-the-art critical care therapy. CAL02 is a novel first-in-class broad-spectrum anti-virulence agent being developed as an add-on to standard of care treatment of SCABP. CAL02 consists of proprietary, engineered liposomes that capture and neutralize bacterial toxins known to dysregulate inflammation, cause organ damage, and impede immune defense. A Phase 1 safety and tolerability trial in SCABP patients was successfully completed, in which encouraging trends for efficacy were observed. The results were published in The Lancet Infectious Diseases, where accompanying comments characterized CAL02 as “One step closer to precision medicine for infectious diseases,” describing the study as a “medical breakthrough.”