The U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation for CAL02, an anti-infective agent being developed to treat severe community-acquired bacterial pneumonia as an add-on therapy to standard of care. Combioxin licensed CAL02 to Eagle Therapeuticals in 2021. With QIDP, Eagle expects to receive eight or ten years of regulatory exclusivity upon NDA approval.
SCABP (severe community-acquired bacterial pneumonia) 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 2 study is underway, designed to assess the efficacy and safety of CAL02 administered intravenously in addition to standard of care in patients with SCABP.
Eagle Pharmaceuticals, Inc. announced this week that FDA has granted Qualified Infectious Disease Product (QIDP) Designation under the Generating Antibiotic Incentives Now (GAIN) Act and Fast Track Designation for CAL02. With QIDP, Eagle expects to receive eight or ten years of regulatory exclusivity upon NDA approval. 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.
Scott Tarriff, President and Chief Executive Officer 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.”
In 2021 Eagle Pharmaceuticals entered into a worldwide licensing agreement with Combioxin SA, a Swiss clinical-stage biotech company. Under the Agreement, Eagle Pharmaceuticals will be solely responsible for the further clinical development of Combioxin's CAL02. They will make an upfront payment, followed by additional payments upon achievement of development milestones, regulatory approval and based upon commercial sales.
(Press release / SK)
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