Basilea Launches FORWARD‑IM Phase 3 Trial of Fosmanogepix in Invasive Mold Infections

Basilea Launches FORWARD‑IM Phase 3 Trial of Fosmanogepix in Invasive Mold Infections

(IN BRIEF) Basilea Pharmaceutica has initiated FORWARD‑IM, a global Phase 3 trial evaluating fosmanogepix in adults with invasive mold infections. Building on positive Phase 1 and Phase 2 results—and following the FAST‑IC Phase 3 candidemia trial—this open‑label study will randomize about 160 patients to fosmanogepix versus standard care and enroll a further 60 patients intolerant or refractory to existing treatments. Fosmanogepix, a first‑in‑class antifungal available intravenously and orally, received BARDA funding and FDA Fast Track, Orphan Drug, and QIDP designations. Completion is expected in Q1 2028 under the oversight of PSI CRO AG. The drug was licensed from Amplyx (Pfizer affiliate), with Pfizer holding first‑negotiation rights for commercialization. The program underscores Basilea’s commitment to addressing high‑mortality fungal diseases and expanding its portfolio beyond its established Cresemba® and Zevtera® brands.

(PRESS RELEASE) ALLSCHWIL, 30-Jul-2025 — /EuropaWire/ — Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial‐stage biopharmaceutical company dedicated to tackling severe bacterial and fungal infections, today announced the launch of FORWARD‑IM, a pivotal Phase 3 trial assessing its novel broad‑spectrum antifungal prodrug, fosmanogepix, in adults suffering from invasive mold infections. The study, expected to conclude in Q1 2028, has received funding support from BARDA under HHS’s ASPR initiative (OT 75A50124C00033).

Fosmanogepix, available in both IV and oral formulations and boasting a first‑in‑class mechanism of action, has already demonstrated safety and efficacy across Phase 1 and open‑label Phase 2 studies targeting candidemia (including Candida auris) and invasive mold disease. FORWARD‑IM marks the second registrational Phase 3 effort, following the FAST‑IC trial launched in September 2024 for candidemia and invasive candidiasis.

This open‑label, two‑cohort study will enroll approximately 220 patients with infections caused by Aspergillus spp., Fusarium spp., Lomentospora prolificans, Mucorales, and other multidrug‑resistant molds. In cohort 1, roughly 160 participants will be randomized 2:1 to receive either fosmanogepix or standard‑of‑care therapy; cohort 2 will include about 60 patients who are intolerant of, refractory to, or whose pathogens resist existing treatments—all of whom will receive fosmanogepix. CGI CRO AG, based in Switzerland, will oversee trial management.

Acquired from Amplyx Pharmaceuticals (a Pfizer affiliate) with Pfizer retaining first‑negotiation rights on commercialization post‑Phase 3, fosmanogepix has already earned FDA Fast Track, Orphan Drug, and QIDP designations for multiple indications. “Our Phase 3 program for fosmanogepix underscores its potential to fill critical gaps in antifungal therapy, particularly against multidrug‑resistant molds,” said Dr. Marc Engelhardt, CMO at Basilea. “We’re eager to build on the promising data seen in earlier studies and our expanded access program.”

Invasive mold infections—including aspergillosis and rare mold diseases—pose life‑threatening risks to immunocompromised populations and carry high morbidity and mortality. Invasive candidiasis, a leading cause of hospital‐acquired bloodstream infections, similarly remains associated with poor outcomes despite current antifungals. Basilea, which commercialized Cresemba® and Zevtera®, continues to advance its anti‑infective pipeline to meet these urgent medical needs.

About fosmanogepix

Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-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.[2] Fosmanogepix intravenous and oral formulations have been evaluated in phase 2 studies for the treatment of patients with Candidemia, including Candida auris, and invasive mold infections.[4, 5, 6] Fosmanogepix has received Fast Track and Orphan Drug designations from the US Food and Drug Administration (FDA) for seven separate indications, and is designated as a Qualified Infectious Disease Product (QIDP).

About invasive mold infections

Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., Lomentospora prolificans, Scedosporium spp., and Mucorales fungi) are life-threatening infections that predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.[8, 9]

About invasive candidiasis

Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients hospitalized in intensive care units. Candida species are ranked as the fourth main cause of bloodstream infections in hospitals in the US.[10] The prognosis of invasive candidiasis remains unfavorable, with a reported mortality rate as high as 40%, even when patients receive antifungal therapy.[11]

About Basilea

Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements, such as “believe”, “assume”, “expect”, “forecast”, “project”, “may”, “could”, “might”, “will” or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

This press release can be downloaded from www.basilea.com.

References

1. FORWARD-IM (FOsmanogepix study Run Worldwide as Antifungal treatment in Resistant Disease caused by Invasive Molds): ClinicalTrials.gov identifier: NCT06925321
2. K. J. Shaw, A. S. Ibrahim. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239
3. M. R. Hodges, E. Ople, P. Wedel et al. Safety and Pharmacokinetics of Intravenous and Oral Fosmanogepix, a First-in-Class Antifungal Agent, in Healthy Volunteers. Antimicrobial Agents and Chemotherapy 2023 (67), e01623-22
4. J. A. Vazquez, P. G. Pappas, K. Boffard et al. Clinical Efficacy and Safety of a Novel Antifungal, Fosmanogepix, in Patients with Candidemia Caused by Candida auris: Results from a Phase 2 Trial. Antimicrobial Agents and Chemotherapy2023 (67), e01419-22
5. P. G. Pappas, J. A. Vazquez, I. Oren et al. Clinical safety and efficacy of novel antifungal, fosmanogepix, for the treatment of candidaemia: results from a Phase 2 trial. Journal of Antimicrobial Chemotherapy 2023 (78), 2471-2480
6. M.R. Hodges, M. Tawadrous, O.A. Cornely et al. Fosmanogepix for the Treatment of Invasive Mold Diseases Caused by Aspergillus Species and Rare Molds: A Phase 2, Open-Label Study (AEGIS). Clinical Infectious Diseases 2025 Apr 9:ciaf185
7. FAST-IC (Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis): ClinicalTrials.gov identifier: NCT05421858
8. J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434
9. M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10
10. Candidemia (Blood Infection) and Other Candida Infections. 2019 Factsheet by the American Thoracic Society: www.thoracic.org/patients/patient-resources/resources/candidemia.pdf (Accessed: July 28, 2025)
11. B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456

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SOURCE: Basilea