Eagle Pharmaceuticals Announces Phase 2 Study for Anti-Toxin Drug Candidate for SCABP

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Eagle Pharmaceuticals randomized its first patient in the Phase 2 study of CAL02, a safe and promising anti-toxin drug that treats severe community-acquired bacterial pneumonia without contributing to antibiotic resistance.

Bacterial Pneumonia   (Adobe Stock, unknown)

Bacterial Pneumonia

(Adobe Stock, unknown)

Although antibiotics have significantly reduced mortality rates for many infections over the past 80 years, the death rate from pneumonia remains unchanged. In addition, more than 30% of pneumococcal bacteria have become resistant to one or more antibiotics, highlighting the need for a new treatment for bacterial pneumonia.

Eagle Pharmaceuticals has recently reported that it has successfully randomized its first patient in the Phase 2 study of CAL02. CAL02 is a promising anti-toxin drug candidate that works alongside antibiotics to treat severe community-acquired bacterial pneumonia (SCABP). It is worth noting that CAL02 does not contribute to the development of antibiotic resistance, which makes it a safe and essential treatment option.

“Severe community-acquired bacterial pneumonia is prevalent worldwide, often fatal, and incurs significant healthcare costs," Valentin Curt, MD, senior vice president, Clinical Drug Development, and interim chief medical officer for Eagle Pharmaceuticals told ICT. “Treatment failures are common and often attributed to virulence factors and antibiotic resistance. CAL02 is a novel agent in its Phase 2 study designed to neutralize bacterial virulence factors without contributing to antibiotic resistance. We believe CAL02 could represent a paradigm shift in terms of the treatment cascade for severe community-acquired bacterial pneumonia patients.”

Valentin Curt, MD, senior vice president, Clinical Drug Development, and interim chief medical officer for Eagle Pharmaceuticals, Inc.  (Photo courtesy of Eagle Pharmaceuticals, Inc.)

Valentin Curt, MD, senior vice president, Clinical Drug Development, and interim chief medical officer for Eagle Pharmaceuticals, Inc.

(Photo courtesy of Eagle Pharmaceuticals, Inc.)

The intravenous treatment uses liposomes to clear virulence factors produced by bacteria, which cause severe and resistant infections. Even after antibiotics clear the bacteria, lingering toxins can still damage organs and perpetuate inflammation. CAL02 can reduce these adverse effects.

The study aims to evaluate the effectiveness and safety of CAL02, given intravenously, in combination with standard of care for patients with severe community-acquired bacterial pneumonia (SCABP). The study will enroll approximately 276 individuals across more than 100 centers in over 20 countries worldwide. Further information about the study can be found on ClinicalTrials.gov. Eagle Pharmaceuticals, Inc aims to have roughly 50 centers operational by the end of September and 100 centers by the end of the year, in preparation for pneumonia season. The first interim report, covering 50% of the study, is expected around the first quarter of 2024, depending on recruitment rates.

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