Basilea initiates phase 3 study with antifungal fosmanogepix in invasive mold infections

Core Insights - Basilea Pharmaceutica Ltd has initiated the FORWARD-IM study, a phase 3 registrational trial to evaluate the efficacy and safety of fosmanogepix for treating adults with invasive mold infections [2][5] - Fosmanogepix is a first-in-class broad-spectrum antifungal with a novel mechanism of action, available in both intravenous and oral formulations [3][8] - The study aims to address significant gaps in current antifungal therapies, particularly against multidrug-resistant molds and yeasts [5] Company Overview - Basilea Pharmaceutica Ltd is a commercial-stage biopharmaceutical company founded in 2000, headquartered in Switzerland, focused on developing innovative drugs for severe bacterial and fungal infections [12] - The company has successfully launched two hospital brands: Cresemba for invasive fungal infections and Zevtera for bacterial infections [12] - Basilea acquired fosmanogepix from Amplyx Pharmaceuticals, an affiliate of Pfizer Inc, which retains a right of first negotiation for commercialization post-phase 3 development [6] Study Details - The FORWARD-IM study is an interventional, open-label, two-cohort phase 3 trial involving approximately 220 patients with invasive mold infections caused by various resistant molds [5] - The first cohort will include around 160 patients randomized to receive either fosmanogepix or standard-of-care therapy, while the second cohort will consist of about 60 patients intolerant to or resistant to standard treatments, all receiving fosmanogepix [5] - Completion of the study and publication of results are expected in Q1 2028 [2][5] Product Information - Fosmanogepix has shown activity against common and rare fungal species, including multi-drug-resistant strains, and has received Fast Track and Orphan Drug designations from the FDA for seven indications [8] - The drug has been evaluated in earlier clinical studies, demonstrating promising efficacy and safety profiles [5][8] Industry Context - Invasive mold infections, particularly those caused by Aspergillus and rare molds, are life-threatening and predominantly affect immunocompromised patients, leading to high morbidity and mortality rates [10] - Invasive candidiasis is a significant nosocomial infection, with Candida species being a leading cause of bloodstream infections in hospitals, and a mortality rate as high as 40% even with antifungal therapy [11]