EGRX - Eagle Pharmaceuticals to Present CAL02 Trial in Progress at the 2023 ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance | Benzinga
-- CAL02 is a unique therapeutic agent that is designed to work differently from antibiotics, aiming to disarm an infectious pathogen's virulence factors to reduce damage and mitigate disease --
-- The first-in-human study showed positive safety and efficacy when added to standard of care in patients with severe community-acquired bacterial pneumonia --
WOODCLIFF LAKE, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that its abstract describing the global in-progress Phase 2 study of CAL02, a first-in-class, broad-spectrum, anti-virulence agent under development as an adjunct to antibiotic therapy for the treatment of severe community-acquired bacterial pneumonia ("SCABP"), has been selected for a poster presentation at the conference co-sponsored by the American Society for Microbiology ("ASM") and the European Society for Clinical Microbiology and Infectious Diseases ("ESCMID"). This prestigious, multidisciplinary meeting is focused on the challenges, opportunities, and current requirements for antimicrobial drug development to address antimicrobial resistance. The conference is scheduled to take place September 19-22, 2023, in Boston, Massachusetts.
"We are pleased to have the opportunity to present additional details of the CAL02 study in progress to our esteemed colleagues," stated Valentin Curt, MD, Senior Vice President, Clinical Drug Development and Interim Chief Medical Officer at Eagle Pharmaceuticals. "Inclusion at this scientific congress supports the significance of the potential clinical value of CAL02 to address a large, unmet medical need. Antimicrobial resistance is one of the world's most urgent public health challenges, and SCABP is a 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 has the potential to mitigate organ damage, pro-inflammatory responses, and to facilitate killing the underlying pathogen, without contributing to antibiotic resistance We look forward to sharing details of the study, its progress, as well as of CAL02's potential to redefine the treatment of SCABP without contributing to antibiotic resistance," concluded Curt.
Details of the poster presentation are as follows:
| Abstract |
| Title: |
| A Randomized, Double-Blind, Placebo Controlled Multicenter Study to Evaluate the Efficacy and Safety of CAL02 Administered Intravenously in Addition to Standard of Care (SOC) in Subjects with Severe Community-Acquired Bacterial Pneumonia (SCABP) |
| Date: |
| September 20, 2023 |
| Time: |
| 3:35pm ET |
| Location: |
| Poster Presentations Session I |
In June 2023, the U.S. Food and Drug Administration ("FDA") granted Qualified Infectious Disease Product ("QIDP") Designation and Fast Track Designation for ...