Fosmanogepix

The latest funding will support an ongoing phase 3 study of fosmanogepix in yeast infections.\n Basilea Pharmaceutica has accessed the next tranche of U.S. government funding required to continue developing its pipeline of new antifungals.The Biomedical Advanced Research and Development Authority (BARDA) signed an agreement with Basilea in September 2024 to provide funding spread over up to 12 years to “support the development of designated novel, first-in-class antifungals and antibacterials in Basilea’s portfolio.” The total funding to be handed over could top out at $268 million, but this is dependent on Basilea hitting a series of clinical and regulatory milestones, as well as BARDA choosing to extend the contract.Basilea already secured $29 million to develop its antifungals fosmanogepix and BAL2062, and the Swiss company announced this morning that it has confirmed it will also receive its next tranche of $39 million after hitting one of those undisclosed milestones.The latest funding will support an ongoing phase 3 study with fosmanogepix in yeast infections as well as launch another late-stage trial in mold infections. The broad-spectrum antifungal originates at Amplyx Pharmaceuticals, although Basilea acquired the asset from Pfizer in 2023.A portion of the fresh funds will also be used to prepare for a phase 2 study of BAL2062. Basilea bought that antifungal from Gravitas Therapeutics and has been aiming the candidate at molds like Aspergillus.“We are very pleased to receive the continued funding under the [agreement] with BARDA to support the development of our antifungal drug candidates fosmanogepix and BAL2062,” Basilea CEO David Veitch said in the July 8 release.“Both compounds offer a novel mechanism of action and represent new therapeutic options for patients with aspergillosis, candidiasis or other life-threatening fungal infections,” Veitch added. “These infections primarily affect patients with weakened immune systems, such as cancer or transplant patients.” Basilea’s relationship with BARDA stretches back to 2013 when the agency committed $89 million in funding toward the antibiotic BAL30072—although the biotech went on to scrap the candidate three years later.Basilea currently markets Cresemba for invasive fungal infections and Zevtera for bacterial infections. The low return on investment means many of the biggest biopharmas have given up working on new antifungals or antibiotics in recent years—although GSK in particular has continued to sign deals and post encouraging clinical results against infections like gonorrhea.Meanwhile, Basilea has swum against the tide, pivoting away from cancer toward anti-infectives in 2023.

April 16, 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 scientific presentations on Basilea’s clinical-stage novel antifungal fosmanogepix given at ESCMID Global 2025, the annual meeting of the European Society of Clinical Microbiology and Infectious Diseases, which took place from April 11 to 15, 2025 in Vienna, Austria. Further presentations covered the antifungal isavuconazole (Cresemba®) and the antibiotic ceftobiprole (Zevtera®). Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “Invasive fungal infections are an increasing global health problem and novel antifungals are urgently needed. To date more than 250 patients suffering from difficult-to-treat invasive fungal infections have received fosmanogepix via expanded access. The data presented at ESCMID highlight the potential of fosmanogepix as a life-saving treatment option in severe fungal infections, based on the results from a large cohort of patients with invasive fusariosis, as well as from patients with mucormycosis, who received fosmanogepix via expanded access. We look forward to the start of our second phase 3 study with fosmanogepix covering a broad range of mold infections, including aspergillosis, fusariosis and mucormycosis.” More than 250 patients from 11 countries with serious or life-threatening invasive fungal infections, who progressed on antifungal standard-of-care treatment, experienced treatment-limiting toxicities, or had infections with resistant fungal pathogens, received fosmanogepix via expanded access to date (NCT06433128). As presented at ESCMID, treatment with fosmanogepix resulted in favorable response rates of 70% or higher in patients with invasive fusariosis or mucormycosis and it was tolerated for long treatment durations. Further presentations reported on the activity of fosmanogepix against diverse yeast and mold species collected as part of a worldwide surveillance program. — Presentation IPT13: Fosmanogepix – a novel clinical phase 3 stage antifungal agent – M. Engelhardt — Presentation O0419: Fosmanogepix expanded access in patients withFusariuminfections – S. Dadwal, A. Baluch, J. Dickter, J. R. Newman, M. H. Nguyen, R. Weihe, H. Schlamm, L. Ostrosky-Zeichner — Poster P4164: Fosmanogepix expanded access case series in patients with mucormycosis – A. Puing, A. Kaur, Y. J. Lee, P.Chang, A. Koff, D. Tyungu, M. Oldham, M. Shaughnessy, A. Tande, H. Schlamm, J. Maertens — Poster E0237:Activity of manogepix against a worldwide collection of mould isolates from 2023–M. Winkler, S. Edeker, A. Klauer, P. R. Rhomberg, M. Castanheira — Poster P2891:Activity of manogepix against a worldwide collection of yeast isolates from 2023–M. Winkler, S. Edeker, A. Klauer, P. R. Rhomberg, M. Castanheira — Poster P2944: Deciphering Connections between Isavuconazole (ISAV) Drug Exposures and Responses Among Different Infections: Mucorales – L. Kovanda, A. Desai — Poster P2945: Deciphering Connections Between Isavuconazole Drug Exposures and Responses Among Different Infections: Dimorphic Fungi/Mould/Other Filamentous Fungi and Mixed Infections – A. Desai, L. Kovanda — Poster P2946: Deciphering Connections Between Isavuconazole Drug Exposures and Responses Among Different Infections: Invasive Candidiasis – L. Kovanda, A. Desai — Poster E0050: Enhancing Isavuconazole Pharmacokinetics: A Comprehensive Population (PPK) Model from Three Phase 3 Trials and Covariate Exploration – A. Desai, L. Kovanda — Poster E0055: High-dose isavuconazole therapy is well-tolerated and significantly improves survival in a fruit fly model of invasive mucormycosis – S. Wurster, N. D. Albert, N. P. Wiederhold, R. E. Lewis, D. P. Kontoyiannis Ceftobiprole (Zevtera) data presented at ESCMID Global 2025 — Poster E0792: Ceftobiprole alone versus in combination with ampicillin against borderline penicillin-resistant, vancomycin-resistant Enterococcus faecalis – O. Funk, I. Khan, J. Li, J. Cusumano 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., Scedosporium spp., and some fungi from the Mucorales order.1 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris infections, and invasive mold infections.1 A phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis is ongoing.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the US Food and Drug Administration for seven separate indications, and is designated as a Qualified Infectious Disease Product (QIDP). This project has been 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. Cresemba, with the active ingredient isavuconazole, is an intravenous (i.v.) and oral azole antifungal. In the 27 European Union member states, as well as in Iceland, Liechtenstein and Norway, isavuconazole is approved for patients aged from 1 year of age and older for the treatment of invasive aspergillosis and for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate.3 Isavuconazole is also approved in the United States (US)4 and several additional countries in Europe and beyond, including the United Kingdom5, the Middle East and North Africa region, the Asia Pacific region, China and Japan.6 It has orphan drug designation in the US, Europe and Australia for its approved indications. Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria.7 In several countries in Europe and beyond, the brand is currently approved and marketed as Zevtera® and Mabelio® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP).7 In the United States, ZEVTERA® is indicated for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).8 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). References 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 Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis (FAST-IC): ClinicalTrials.gov identifier: NCT05421858 European Public Assessment Report (EPAR) Cresemba: https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: April 15, 2025] Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: April 15, 2025] Summary of Product Characteristics (SmPC) Cresemba: https://www.medicines.org.uk/emc/search?q=cresemba [Accessed: April 15, 2025] The registration status and approved indications may vary from country to country. Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc [Accessed: April 15, 2025] The content above comes from the network. if any infringement, please contact us to modify.