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Eagle Pharmaceuticals Commences Phase 2 Trial to Investigate CAL02, a Groundbreaking Anti-Toxin Drug Candidate, for Severe Community-Acquired Bacterial Pneumonia (SCABP)

Tuesday, July 25, 2023

Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) made an announcement regarding the initiation of its Phase 2 study for CAL02, a groundbreaking anti-toxin drug candidate, in patients with severe community-acquired bacterial pneumonia (SCABP). The study is designed as an adaptive, randomized, double-blind, placebo-controlled trial and aims to evaluate the safety and efficacy of CAL02 when administered intravenously in addition to standard of care for SCABP. The enrollment for the Phase 2 trial is expected to include approximately 276 patients at more than 100 sites across over 20 countries globally.

SCABP is a worldwide prevalent infectious disease that has been associated with high morbidity and mortality, despite the availability of vaccines, effective antibiotic regimens, and advanced critical care therapy. CAL02, the novel first-in-class broad-spectrum anti-virulence agent, is being developed to act as an add-on therapy to the standard of care for SCABP. It consists of proprietary, engineered liposomes that target and neutralize bacterial toxins responsible for inflammation dysregulation, organ damage, and weakened immune defense. Previous Phase 1 safety and tolerability trials in SCABP patients showed encouraging trends for efficacy, and the results were published in The Lancet Infectious Diseases, which described CAL02 as "One step closer to precision medicine for infectious diseases" and hailed the study as a "medical breakthrough."

Eagle Pharmaceuticals' President and CEO, Scott Tarriff, emphasized the need for more effective treatment options for patients with severe bacterial pneumonia. CAL02's unique approach targets virulence factors produced by a majority of common pathogens, suggesting it could have broad utility in treating SCABP. The company is committed to advancing the clinical program and expects to have approximately 50 sites operational by the end of September, with 100 sites running by the end of the year, just in time for the global pneumonia season. Depending on recruitment rates, the company anticipates releasing its first interim report around the first quarter of 2024.

Dr. Valentin Curt, Senior Vice President of Clinical Drug Development and Interim Chief Medical Officer for Eagle Pharmaceuticals, highlighted that virulence factors play a crucial role in severe, complicated, and resistant bacterial infections, with mortality rates for intensive care unit pneumonia patients remaining high worldwide. CAL02, as a first-in-class, broad-spectrum anti-virulence agent, targets the most common virulence factors, offering potential benefits such as mitigating organ damage, reducing pro-inflammatory responses, and aiding in pathogen elimination without contributing to antibiotic resistance. The company is enthusiastic about the opportunity to expand on the promising results from the Phase 1 first-in-human study and hopes to provide additional treatment options for critical care and infectious disease physicians to advance SCABP patient care.

Eagle Pharmaceuticals believes that CAL02 could be eligible for breakthrough therapy and new chemical entity (NCE) designations. To protect the intellectual property resulting from the development of this novel therapy, the company is further developing the patent estate for CAL02. The drug is currently protected by an issued U.S. Patent No.10,744,089, set to extend until September 2035, with the possibility of a Patent Term Extension of up to five years until 2040. CAL02 is also protected by granted counterparts in significant markets globally, including Europe and Japan, and additional patent families are pending for future protection. In August 2021, Eagle Pharmaceuticals secured a worldwide licensing agreement with Combioxin SA for the commercial rights to CAL02.

The Phase 2 adaptive, randomized, double-blind, placebo-controlled study will enroll approximately 276 patients with SCABP globally. The study aims to assess the efficacy and safety of CAL02 administered intravenously in addition to standard of care.

CAL02 is an investigational, innovative, first-in-class anti-infective agent acting as a competitive decoy for bacterial virulence factors. These factors contribute to infection-related complications, sepsis, septic shock, and death. CAL02 consists of proprietary liposomes engineered to capture the virulence factors produced by a broad range of Gram-positive and Gram-negative bacteria that cause severe infectious diseases, including severe pneumonia. The drug could potentially play a vital role in the fight against antimicrobial resistance, complementing the action of antibiotics without exerting selective pressure that could contribute to antibiotic resistance. The characteristics of CAL02 make it a promising candidate to be administered empirically in combination with standard of care once severe pneumonia symptoms are detected. The clinical results so far underscore CAL02's potential to revolutionize standard care and significantly reduce treatment time and costs for critically ill SCABP patients. Eagle Pharmaceuticals holds a worldwide exclusive license for CAL02 acquired from Combioxin SA.

Virulence factors are produced by pathogens and enable their ability to infect a host and cause disease. Blocking the activities of virulence factors is a relatively new approach to disarm infectious pathogens. Anti-virulence drugs specifically target these factors, showing promise as a way to combat severe and resistant bacterial infections.



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