BARDA is providing additional support to Basilea Pharmaceutica International Ltd (Basilea) to continue and complete Phase 3 clinical trials of an antibiotic candidate, ceftobiprole. The completion of these studies is necessary for the company to seek FDA approval of ceftobiprole to treat bloodstream infections caused by Staphylococcus aureus bacteria. This continued funding represents partial funding as this is a cost sharing arrangement with the company and highlights the commitment of both parties to bring novel antimicrobials forward to potential FDA approval.
Staphylococcus aureus infections can lead to sepsis, one of the most common causes of death in U.S. hospitals. The Centers for Disease Control and Prevention estimates that 270,000 people die from sepsis every year in the Unite States. BARDA awarded the contract to Basilea in 2016 to evaluate ceftobiprole in two Phase 3 clinical trials to treat bacterial skin infections and bloodstream infections.
Ceftobiprole is a broad-spectrum antibiotic that targets Gram-positive and Gram-negative bacterial pathogens. In addition, because of the ceftobiprole’s novel mechanism of action, bacteria are less likely to become resistant to the drug.
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Basilea is a mid-sized commercial-stage biopharmaceutical company headquartered in Basel, Switzerland. Basilea focuses on the development of innovative products that address the medical challenges in the oncology and infectious diseases therapeutic areas. In addition to ceftobiprole, Basilea’s portfolio includes isavuconazole (trade name Cresemba, an antifungal for treatment of invasive aspergillosis and mucormycosis), the clinical-stage oncology drugs lisavanbulin and derazantinib, and a number of earlier-stage compounds in the antibacterial and oncological spaces.