Basilea Pharmaceutica Ltd announced the initiation of FORWARD-IM, a phase 3 registrational study evaluating the efficacy and safety of its broad-spectrum antifungal fosmanogepix for treating adult patients with invasive mold infections. The Swiss biopharmaceutical company expects study completion and publication of results in Q1 2028.
Novel Antifungal Addresses Critical Treatment Gap
Fosmanogepix represents a first-in-class antifungal with a novel mechanism of action, available in both intravenous and oral formulations. The drug has demonstrated activity against common species of Candida and Aspergillus, including multidrug-resistant strains such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Lomentospora prolificans, Scedosporium spp., and some fungi from the Mucorales order.
"Our phase 3 program with fosmanogepix allows us to fully explore the clinical benefit of this important new treatment option for invasive fungal infections," said Dr. Marc Engelhardt, Chief Medical Officer of Basilea. "Its broad-spectrum activity against multidrug-resistant molds and yeasts highlights the unique potential of fosmanogepix to address significant gaps in current antifungal therapies."
Comprehensive Phase 3 Study Design
FORWARD-IM is designed as an interventional, open-label, two-cohort phase 3 study targeting adult patients with invasive mold infections caused by Aspergillus spp., Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multidrug-resistant molds.
The first cohort will enroll approximately 160 patients, randomized in a 2:1 ratio to receive either fosmanogepix or current standard-of-care therapy. The second cohort will enroll approximately 60 patients who have developed intolerance, toxicities, lack of clinical response, or whose fungal isolate is resistant to standard-of-care therapy. All patients in the second cohort will receive fosmanogepix.
Expanding Clinical Development Program
This phase 3 trial represents the second registrational study for fosmanogepix, following the initiation of FAST-IC in September 2024, a randomized, double-blind phase 3 study in adult patients with candidemia and invasive candidiasis. The drug has previously been evaluated in phase 1 and phase 2 programs, including three open-label phase 2 studies for treating candidemia, including Candida auris, and invasive mold infections.
Fosmanogepix has received Fast Track and Orphan Drug designations from the US Food and Drug Administration for seven separate indications and is designated as a Qualified Infectious Disease Product (QIDP).
Addressing Life-Threatening Infections
Invasive aspergillosis and invasive infections with rare molds are life-threatening conditions that predominantly affect immunocompromised patients, including those with hematologic malignancies, transplant recipients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality rates.
Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, represents an increasingly important nosocomial infection, particularly in intensive care unit patients. Candida species rank as the fourth main cause of bloodstream infections in US hospitals, with mortality rates reaching as high as 40% even when patients receive antifungal therapy.
Strategic Partnerships and Funding
Basilea acquired fosmanogepix from Amplyx Pharmaceuticals, Inc., an affiliate of Pfizer Inc. Pfizer retains a right of first negotiation for commercializing fosmanogepix upon successful completion of phase 3 development. The Swiss-based global company PSI CRO AG is managing the phase 3 program.
The project receives partial funding from federal sources through the U.S. Department of Health and Human Services, Administration of Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority under contract number 75A50124C00033.
