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

• Study to evaluate the efficacy and safety of fosmanogepix in adults with invasive mold infections
• Study completion expected in Q1 2028

Allschwil, Switzerland, July 29, 2025

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today the initiation of FORWARD-IM, a phase 3 registrational study evaluating the efficacy and safety of its broad-spectrum antifungal fosmanogepix for the treatment of adult patients with invasive mold infections.[1]

Fosmanogepix is a first-in-class antifungal with a novel mechanism of action and is available in both intravenous and oral formulations. It has been evaluated for efficacy and safety in a phase 1 and phase 2 program, including three open-label phase 2 studies for the treatment of Candidemia, including Candida auris, and invasive mold infections.[2, 3, 4, 5, 6]

The FORWARD-IM study is the second phase 3 study for fosmanogepix, following the initiation of FAST-IC in September 2024, a randomized, double-blind phase 3 registrational study in adult patients with candidemia and/or invasive candidiasis.[7]

Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “Our phase 3 program with fosmanogepix allows us to fully explore the clinical benefit of this important new treatment option for invasive fungal infections. Its broad-spectrum activity against multidrug-resistant molds and yeasts highlights the unique potential of fosmanogepix to address significant gaps in current antifungal therapies. Fosmanogepix has shown promising efficacy in earlier clinical studies and in the ongoing expanded access program. The initiation of our second phase 3 study is a significant milestone for fosmanogepix and demonstrates our commitment to advancing our innovative pipeline for the benefit of patients.”

FORWARD-IM is an interventional, open-label, two-cohort phase 3 study in 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. The completion of the study and publication of results are expected in 2028. The Swiss-based global company PSI CRO AG is managing the phase 3 program.

Basilea acquired fosmanogepix from Amplyx Pharmaceuticals, Inc., an affiliate of Pfizer Inc. Pfizer retains a right of first negotiation for commercializing fosmanogepix, once phase 3 development is successfully completed.

This project is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration of Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50124C00033. The contract and federal funding are not an endorsement of the study results, product, or company.

Full PR available here