Eagle Pharmaceuticals Announces First Patient Randomized in Phase 2 Study Evaluating CAL02, a Novel First-in-Class Anti-Toxin Drug Candidate, in Severe Community-Acquired Bacterial Pneumonia (SCABP)

Despite the availability of antibiotics, the death rate from pneumonia in the U.S. has seen little improvement in the past half century¹

– CAL02 is a unique therapeutic agent that works differently from antibiotics, disarming an infectious pathogen’s virulence factors to reduce damage and mitigate disease –

– CAL02 has been designed to neutralize a broad range of bacterial toxins to lessen the virulence effect on disease progression and severity –

– With its unique mechanism of action, CAL02, an adjunctive therapy to standard of care, including antibiotics, has the potential to redefine the treatment of SCABP without contributing to antibiotic resistance –

– Company believes CAL02 is a new chemical entity (NCE), which would result in five years of marketing exclusivity upon approval or three years without NCE designation –

– CAL02 received FDA Fast-Track and Qualified Infectious Disease Product (QIDP) Designations, Providing Five-Year Exclusivity Extension; total potential of eight or ten years of exclusivity –

WOODCLIFF LAKE, N.J., July 24, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that the first patient has been randomized in its multi-center adaptive, randomized, double-blind, placebo-controlled Phase 2 study designed to assess the efficacy and safety of CAL02 administered intravenously in addition to standard of care in patients with severe community-acquired bacterial pneumonia (SCABP). The Phase 2 study plans to enroll approximately 276 patients with SCABP at more than 100 sites in over 20 countries worldwide. Additional details are available on ClinicalTrials.gov (Identifier: NCT05776004). The Company expects to have approximately 50 sites up and running by the end of September, with 100 sites up by year-end in readiness for the global pneumonia season. In addition, depending upon recruitment rates, Eagle anticipates having its first 50% interim report around the first quarter of 2024.

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.”