Basilea Pharmaceutica announced it has secured an additional $39 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) to advance development of its novel antifungal drug candidates fosmanogepix and BAL2062. The funding milestone was achieved under the Other Transaction Agreement (OTA) awarded in September 2024, which provides potential total funding of up to $268 million over 12 years.
The latest funding brings BARDA's total commitment to $68 million, following an initial $29 million provided at the OTA signing. BARDA's contribution represents approximately 60% of total project costs, with funding contingent on successful completion of pre-defined clinical and regulatory milestones.
Addressing Critical Unmet Medical Needs
David Veitch, Chief Executive Officer of Basilea, emphasized the urgent medical need these compounds address: "Both compounds offer a novel mechanism of action and represent new therapeutic options for patients with aspergillosis, candidiasis or other life-threatening fungal infections. These infections primarily affect patients with weakened immune systems, such as cancer or transplant patients."
The funding comes as infections with difficult-to-treat rare molds and resistance to current therapies continue to increase, creating significant challenges for clinicians treating immunocompromised patients.
Fosmanogepix: Broad-Spectrum Antifungal in Late-Stage Development
Fosmanogepix represents a clinical-stage broad-spectrum antifungal with a novel mechanism of action. The compound has demonstrated activity against common species of Candida and Aspergillus, including multi-drug-resistant strains such as Candida auris and Candida glabrata. Additionally, it shows efficacy against rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.
The drug candidate has been evaluated in Phase 2 studies for treating patients with candidemia, including Candida auris infections, and invasive mold infections. A Phase 3 study evaluating fosmanogepix for adult patients with candidemia and/or invasive candidiasis is currently ongoing, with a second Phase 3 study in invasive mold infections expected to begin soon.
Fosmanogepix has received Fast Track and Orphan Drug designations from the FDA for multiple indications and is designated as a Qualified Infectious Disease Product (QIDP).
BAL2062: First-in-Class Natural Product Derivative
BAL2062 represents a first-in-class antifungal derived from a natural product, demonstrating fungicidal activity against clinically important molds such as Aspergillus spp., including azole-resistant strains. The compound has completed Phase 1 safety and tolerability studies with single and multiple ascending intravenous doses.
The drug candidate has received QIDP, Orphan Drug, and Fast Track designations from the FDA for invasive aspergillosis. The current funding will support preparation for Phase 2 studies of BAL2062.
Targeting High-Mortality Infections
The antifungal candidates address infections with significant clinical impact. Invasive aspergillosis and infections with rare molds are life-threatening conditions that predominantly affect immunocompromised patients, including those with hematologic malignancies, transplant recipients, and patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.
Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, represents an increasingly important nosocomial infection, particularly in intensive care units. Candida species rank as the fourth main cause of bloodstream infections in U.S. hospitals, with invasive candidiasis carrying a mortality rate as high as 40% even with antifungal therapy.
Strategic Partnership with BARDA
The BARDA partnership reflects the strategic importance of developing new antifungal therapies for national preparedness. The OTA structure allows for milestone-based funding over an extended period, supporting the lengthy development timeline required for anti-infective agents.
Basilea, a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland, has successfully launched two hospital brands: Cresemba for invasive fungal infections and Zevtera for bacterial infections. The company maintains a portfolio of preclinical and clinical anti-infective assets focused on severe bacterial and fungal infections.
