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

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-- 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.

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 https://www.globenewswire.com/Tracker?data=LPYTdIvSuNVq20byHdAy41faTo-CB862BXUcw5KtEbRx_3IkQp4523YZNrnSYw4-XFxHJji82QwzXriJI98_YHdCN6oLGm1wzajxFseudHU=.

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.

For further information, please contact:

Peer Nils Schröder, PhD

Head of Corporate Communications & Investor Relations

Basilea Pharmaceutica International Ltd, Allschwil

Hegenheimermattweg 167b

4123 Allschwil

Switzerland

Phone +41 61 606 1102

E-mail media_relations@basilea.com

investor_relations@basilea.com

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:

https://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

Attachment

-- Press release (PDF)

https://ml-eu.globenewswire.com/Resource/Download/c3fb970b-115f-425a-9fe1-736045a0f766

(END) Dow Jones Newswires

July 29, 2025 01:15 ET (05:15 GMT)