Basilea secures $39M BARDA funding for antifungals fosmanogepix and BAL2062.

Basilea Pharmaceutica Ltd, a biopharmaceutical enterprise headquartered in Allschwil, Switzerland, has received a significant financial boost from the Biomedical Advanced Research and Development Authority (BARDA), a part of the U.S. Department of Health and Human Services. This funding amounts to an additional USD 39 million, aimed at supporting the advancement of Basilea's innovative antifungal drugs, fosmanogepix and BAL2062. This investment follows the successful achievement of a milestone within the "Other Transaction Agreement" (OTA) that began on September 30, 2024. The arrangement has the potential to allocate up to USD 268 million in total for the development of both antifungal and antibacterial treatments.

David Veitch, the Chief Executive Officer of Basilea, expressed satisfaction with the continued financial backing from BARDA. He emphasized the importance of fosmanogepix and BAL2062 in providing new treatment options for severe fungal infections such as aspergillosis and candidiasis, particularly in patients with weakened immune systems. These conditions are increasing in incidence, especially in cases involving treatment-resistant pathogens or rare molds, underscoring the critical need for innovative antifungal therapies.

The recent funding will facilitate ongoing clinical trials, including a phase 3 study of fosmanogepix for yeast infections and an impending phase 3 study focusing on mold infections. Additionally, it will aid in the preparation of a phase 2 study for BAL2062. This financial injection supplements the initial USD 29 million committed by BARDA when the OTA was signed in September 2024. BARDA's contribution covers approximately 60% of the total project costs over the duration of the agreement, potentially providing up to USD 268 million in non-dilutive funding over 12 years, contingent upon the successful completion of specific milestones and the exercise of options to extend the contract.

Fosmanogepix is positioned as a broad-spectrum antifungal agent currently in the clinical development stage. It functions through a novel mechanism of action, showing efficacy against common fungal pathogens like Candida and Aspergillus, including strains resistant to multiple drugs such as Candida auris. The drug has been evaluated in phase 2 clinical trials for treating candidemia and invasive mold infections. It is currently undergoing a phase 3 trial for candidemia and invasive candidiasis, with another phase 3 trial for mold infections anticipated. The U.S. Food and Drug Administration (FDA) has granted fosmanogepix Fast Track, Orphan Drug, and Qualified Infectious Disease Product (QIDP) designations for various indications.

BAL2062, a first-in-class antifungal agent derived from natural products, has demonstrated significant activity against clinically relevant molds, including azole-resistant Aspergillus strains. Its safety and tolerability have been established in a phase 1 study involving ascending intravenous doses. Like fosmanogepix, BAL2062 has received QIDP, Orphan Drug, and Fast Track designations from the FDA for its application in treating invasive aspergillosis.

Invasive mold infections, such as aspergillosis, pose severe health risks, particularly to patients with compromised immune systems, including those with blood cancers or undergoing transplants. These infections are associated with high mortality and morbidity. Similarly, invasive candidiasis, including candidemia, is a significant hospital-acquired infection, particularly in intensive care units. Despite treatment, this condition maintains a high mortality rate, emphasizing the need for new and effective antifungal therapies.

Basilea Pharmaceutica Ltd, founded in 2000, is dedicated to developing and commercializing innovative pharmaceuticals for treating severe bacterial and fungal infections. The company, listed on the SIX Swiss Exchange, has successfully launched two hospital brands, Cresemba and Zevtera, and continues to progress its portfolio of anti-infective assets.