Basilea Pharmaceutica, Ltd., presented scientific data on its antifungal treatment isavuconazole (Cresemba) and antibiotic ceftobiprole (Zevtera) in a number of poster and oral presentations at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), recently held in Amsterdam.
Cresemba is an antifungal drug approved by the U.S. Food and Drug Administration (FDA) to treat adults with two life-threatening fungal infections: invasive aspergillosis and mucormycosis. It has similar approval in Europe, expect that patients there with mucormycosis are approved to use Cresemba only when amphotericin B treatment is inappropriate. The number of people with these diseases is low, and they are considered rare. The drug has subsequently been designated an orphan medicine in both Europe and the U.S.
Data on isavuconazole included further analyses from the Phase 3 study, SECURE, in invasive aspergillosis, and the results of the Phase 3 ACTIVE study in invasive candidiasis. SECURE is testing the efficacy and safety of isavuconazole compared to voriconazole in patients with invasive mold disease caused by Aspergillus species or other filamentous fungi. Isavuconazole treatment has been reported in the study to be non-inferior to voriconazole for the primary treatment of suspected invasive mold disease, and to show fewer drug-related adverse events. ACTIVE is evaluating isavuconazole compared to caspofungin as the treatment of candidemia and other invasive Candida infections.
Zevtera is a broad-spectrum antibiotic drug intended for use via intravenous administration. Ceftobiprole’s bactericidal activity fights against certain Gram-positive and Gram-negative bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA) and susceptible Pseudomonas species.
Data presented on ceftobiprole included results from a posthoc analysis of people with staphylococcal bacteremia enrolled in four double-blind, randomized, Phase 3 clinical trials in complicated skin or respiratory infections. The studies revealed that clinical responses to ceftobiprole were similar to those for standard-of-care comparators, with a trend toward lower 30-day all-cause mortality with ceftobiprole. Systemic infections caused by Methicillin-susceptible and Methicillin-resistant Staphylococcus aureus are a potentially life-threatening complication of staphylococcal infections elsewhere in the body.
Ceftobiprole is approved for use in 13 European countries and in Canada for the treatment of adults with community-acquired pneumonia and hospital-acquired pneumonia. The drug has been designated a Qualified Infectious Disease Product by the FDA as a potential treatment for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, but is not yet approved for use.
The company also hosted at the Congress symposia on new prospects in the treatment of nosocomial pneumonia, and on challenges and developments in invasive mold infection therapies.