Basilea starts Phase 3 trial of antifungal fosmanogepix for candidemia and invasive candidiasis

Basilea Pharmaceutica Ltd, headquartered in Allschwil, Switzerland, has commenced the FAST-IC phase 3 study to assess the efficacy and safety of its broad-spectrum antifungal candidate, fosmanogepix, in treating invasive candidiasis and candidemia. This pivotal study aims to provide a new treatment option for adults suffering from these severe infections caused by Candida yeast in the bloodstream or deep-seated tissues.

Fosmanogepix distinguishes itself as a first-in-class antifungal agent with a unique mechanism of action. Available in both intravenous and oral formulations, it has already undergone extensive phase 1 and phase 2 clinical testing. These trials included three open-label phase 2 studies focused on treating candidemia, even those cases involving the multidrug-resistant Candida auris, as well as invasive mold infections.

The FAST-IC trial is a global, multi-center, randomized, active-controlled, and double-blind phase 3 study. It will compare intravenous fosmanogepix against the standard-of-care treatment, intravenous caspofungin, in adult patients. Approximately 450 patients are expected to be enrolled and randomized in a 2:1 ratio to receive either fosmanogepix or caspofungin. The trial offers an optional switch to oral fosmanogepix for those in the fosmanogepix group and to fluconazole for those in the caspofungin group. PSI CRO AG, a Swiss-based global contract research organization, will manage the phase 3 program.

Basilea Chief Medical Officer Dr. Marc Engelhardt expressed optimism about the study, emphasizing the urgent need for new treatments for invasive Candida infections, which pose life-threatening risks and have high mortality rates. Dr. Engelhardt also hinted at a forthcoming phase 3 study focused on fosmanogepix for treating invasive mold infections, anticipated to start by the end of the year.

Fosmanogepix was acquired from Amplyx Pharmaceuticals, Inc., an affiliate of Pfizer Inc., in November 2023. As part of the acquisition agreement, Basilea took over all previous rights and obligations. A milestone payment of USD 6.0 million is due upon the enrollment of the first patient, a financial commitment already accounted for in Basilea’s 2024 financial guidance.

The development of fosmanogepix has received partial funding from federal sources, including the U.S. Department of Health and Human Services (HHS) and the Biomedical Advanced Research and Development Authority (BARDA).

Fosmanogepix showcases a broad spectrum of antifungal activity, targeting common Candida and Aspergillus species, including those resistant to multiple drugs like Candida auris and Candida glabrata. It also addresses rare, hard-to-treat molds such as Fusarium spp., Scedosporium spp., and certain Mucorales fungi. The U.S. Food and Drug Administration (FDA) has granted fosmanogepix Fast Track and Orphan Drug designations for seven different indications, and it is also recognized as a Qualified Infectious Disease Product (QIDP).

Invasive mold infections, including aspergillosis and those caused by rare molds, are severe conditions primarily affecting immunocompromised individuals. These infections come with high morbidity and mortality rates, particularly impacting patients with hematologic malignancies, transplant recipients, and those with other immune deficiencies.

Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is a significant nosocomial infection, especially prevalent in intensive care units. In the United States, Candida species rank as the fourth leading cause of bloodstream infections in hospitals. Despite antifungal therapy, the mortality rate for invasive candidiasis remains dauntingly high, reported at up to 40%.

Basilea Pharmaceutica Ltd, established in 2000, is dedicated to discovering, developing, and commercializing innovative treatments for severe bacterial and fungal infections. Based in Switzerland, the company has successfully launched two hospital brands, Cresemba for invasive fungal infections and Zevtera for bacterial infections. Basilea continues to focus on a robust pipeline of preclinical and clinical anti-infective assets. The company is publicly traded on the SIX Swiss Exchange under the ticker symbol BSLN.