Basilea initiates phase 3 clinical trial with antifungal agent fosmanogepix in candidemia and invasive candidiasis | 24.09.24

Allschwil, Switzerland, September 24, 2024

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with serious bacterial and fungal infections, today announced that it has initiated the Phase 3 study Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis (FAST-IC). This registrational study is evaluating the efficacy and safety of Basilea’s broad-spectrum antifungal agent fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis, i.e. Candida yeast infections in the bloodstream or deep-seated tissues.¹

Fosmanogepix is ​​a first-in-class antifungal treatment candidate with a novel mechanism of action. It is available in intravenous and oral formulations and has been evaluated for efficacy and safety in a Phase 1/Phase 2 program, including three open-label Phase 2 studies for the treatment of Candidaemia, including Candida infectionand invasive fungal infections.^{2, 3, 45}

Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “We are very pleased to have activated the first study center in the Phase 3 program for fosmanogepix and look forward to enrolling patients in FAST-IC. Invasive Candida Infections are life-threatening complications for many hospitalized patients and are associated with high mortality, and fosmanogepix offers a potential new treatment option in this high-need area. In addition, we are working to initiate the second Phase 3 study investigating fosmanogepix in the treatment of adult patients with invasive fungal infections by the end of the year.”

FAST-IC is a global, multicenter, randomized, active-controlled, double-blind Phase 3 trial investigating intravenous (IV) fosmanogepix versus a standard of care regimen of IV caspofungin in adult patients with candidemia and/or invasive candidiasis. The trial is expected to enroll approximately 450 patients, who will be randomized 2:1 to receive fosmanogepix or caspofungin. There is an optional oral switch to fosmanogepix in the fosmanogepix group and to fluconazole in the caspofungin group. Switzerland-based global company PSI CRO AG will manage the Phase 3 program.

Basilea acquired fosmanogepix in November 2023 from Amplyx Pharmaceuticals, Inc., a subsidiary of Pfizer Inc. Under the terms of the asset purchase agreement, Basilea assumed all rights and obligations under prior agreements and will make a $6.0 million milestone payment under these obligations upon enrollment of the first patient, which is fully included in Basilea’s most recent full year 2024 financial guidance.

This project was 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 do not constitute an endorsement of the research results, the product, or the company.

About fosmanogepix

Fosmanogepix is ​​a broad spectrum antifungal drug in clinical stage. It has a novel mechanism of action and its active moiety has shown activity against common species Candida And Aspergillusincluding multi-resistant strains, such as Candida infection And Candida glabrataas well as rare, difficult to treat fungi, including Fusarium species, Scedosporium spp., and some fungi from the order Mucorales.² Fosmanogepix intravenous and oral formulations have been evaluated in Phase 2 clinical trials for the treatment of patients with candidemia, including Candida infectionand invasive fungal infections.² Fosmanogepix has been granted Fast Track and Orphan Drug designation by the U.S. Food and Drug Administration for seven separate indications and has been designated a Qualified Infectious Disease Product (QIDP).

About Invasive Fungal Infections

Invasive aspergillosis and invasive infections with rare fungi (e.g. Fusarium species, Scedosporium spp., and Mucorales fungi) are life-threatening infections that primarily affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant recipients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.^{6, 7}

About invasive candidiasis

Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients in the intensive care unit. Candida species are considered the fourth leading cause of bloodstream infections in hospitals in the US.⁸ The prognosis of invasive candidiasis remains difficult, with a reported mortality rate as high as 40%, even when patients receive antifungal therapy.⁹

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 medicines to address the needs of patients suffering from serious 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). Visit basilea.com.

Disclaimer

This communication contains, expressly or implicitly, certain forward-looking statements, such as “believe”, “assume”, “expect”, “predict”, “project”, “may”, “could”, “will” or similar expressions with respect to 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 may 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 the date hereof and undertakes no obligation to update any forward-looking statements contained herein, whether as a result of new information, future events or otherwise.

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

References

1. ClinicalTrials.gov Identifier: NCT05421858
2. KJ Shaw, AS 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. MR 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. JA Vazquez, PG Pappas, K. Boffard et al. Clinical efficacy and safety of a novel antifungal agent, Fosmanogepix, in patients with candidemia caused by Candida auris: results of a phase 2 study. Antimicrobial Agents and Chemotherapy2023 (67), e01419-22
5. PG Pappas, JA Vazquez, I. Oren et al. Clinical safety and efficacy of the novel antifungal agent, fosmanogepix, for the treatment of candidemia: results of a phase 2 study. Journal of Antimicrobial Chemotherapy 2023 (78), 2471-2480
6. J. Cadena, GR Thompson 3rd, TF.Patterson. Aspergillosis: epidemiology, diagnosis and treatment. Infectious Disease Clinics of North America 2021 (35), 415-434
7. M. Slavin, S. van Hal, TC Sorrell et al. Invasive infections by filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10
8. Candidemia (blood infection) and other Candida infections. American Thoracic Society 2019 fact sheet: https://www.thoracic.org/patients/patient-resources/resources/candidemia.pdf (accessed September 23, 2024)
9. BJ Kullberg, MC Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456