An Interventional Phase 3, Open-label, Two-cohort Study to Investigate the Efficacy and Safety of Fosmanogepix in Adult Patients With Invasive Mold Infections Caused by Aspergillus Spp., Fusarium Spp., Lomentospora Prolificans, Mucorales Fungi, or Other Multidrug Resistant Molds

The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period.
The patient will be assigned to one of two treatment cohorts:
Cohort A (primary therapy): Patients will receive either the study drug or institutional standard of care antifungal treatment.
Cohort B (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): Patients will receive the study drug
The primary aim is to compare the all cause mortality with a fixed threshold at Day 42.

Start Date01 Jun 2025

Sponsor / Collaborator

Basilea Pharmaceutica AG

[+1]

NCT05421858

/ RecruitingPhase 3

An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive Candidiasis

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida.
The study is seeking patients who have a diagnosis of candidemia and/or invasive candidiasis.
Two-thirds of all patients will receive the study medication fosmanogepix Intravenous (IV) infusion followed by optional fosmanogepix tablets. One-third of all patients will receive a standard of care regimen of caspofungin Intravenous (IV) infusion followed by optional fluconazole capsules.
Fosmanogepix or caspofungin will first be given as an Intravenous (IV) infusion directly into a vein in the arm each day at the study clinic. Fosmanogepix tablets or fluconazole capsules will be taken orally by mouth daily either at the study clinic, or at home if patients are well enough to be discharged from the hospital.
The treatment effect in patients receiving fosmanogepix to those receiving caspofungin/ fluconazole will be compared. The primary aim is to show that fosmanogepix is not inferior (not worse) to caspofungin/ fluconazole with a noninferiority margin of 15%.
The duration of study treatment and number of study visits will vary depending on how long the patient will be treated for the infection. Treatment will continue for a maximum of 6 weeks depending on when the infection is cleared and whether other symptoms related to the infection have improved. There will also be a follow-up visit 6 weeks after the study treatment was stopped.

Start Date11 Dec 2024

Sponsor / Collaborator

Basilea Pharmaceutica AG

[+1]

NCT05582187

/ RecruitingPhase 1

A Phase 1, Open-label, Single-dose, Parallel Cohort Study to Assess the Pharmacokinetics and Safety of Fosmanogepix (PF 07842805) in Adult Participants With Varying Degrees of Hepatic Impairment

The primary purpose of this open-label study is to characterize the plasma pharmacokinetics (PK) of manogepix (active moiety of fosmanogepix) in participants with varying degrees of hepatic function following administration of a single oral dose of fosmanogepix.
All participants will receive 1 dose of fosmanogepix by mouth before breakfast on the first day at the study clinic. Serial blood samples will be collected to understand how fosmanogepix is changed and eliminated from the body. Participants will also receive physical examination and other tests. This will help to understand if fosmanogepix is safe.
Participants will be involved in this study for 4 to 9 weeks (maximum). There will be 2 to 4 study visits at the study clinic.

Start Date31 Oct 2022

Sponsor / Collaborator

Basilea Pharmaceutica AG

[+1]

100 Clinical Results associated with Fosmanogepix

100 Translational Medicine associated with Fosmanogepix

100 Patents (Medical) associated with Fosmanogepix

Literatures (Medical) associated with Fosmanogepix

01 Dec 2024·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Two cases of fungemia due to Lomentospora prolificans in haematological patients with different outcome

Article

Author: Navarro-Marí, José María ; Cobo, Fernando ; Castellano-Sánchez, Leticia ; González-Sierra, Pedro Antonio ; Ortega-Gavilán, Mª Carmen

Lomentospora prolificans is an uncommon cause of invasive fungal disease, but it is associated with high mortality because it is difficult to treat. Most of severe cases are produced in immunossupressed patients, especially in those with neutropenia and/or hematological malignancies. Resistance to the majority of antifungal agents can be still observed. Here we report two cases of L. prolificans fungemia with different outcome, since in one of these patients treatment with one of the new antifungals could be applied. Both patients were treated with different antifungal drugs, but only the second one survived due to therapy with fosmanogepix®. The current treatment is still based on a combination of conventional antifungal drugs, although in much cases this strategy is not sufficient. The introduction of new promising antifungal agents such as fosmanogepix® and olorofim® may open new perspectives in the treatment of invasive infections caused by L. prolificans, as in our patient.

01 Dec 2024·CURRENT OPINION IN INFECTIOUS DISEASES

Reassessment of the role of combination antifungal therapy in the current era

Review

Author: Neoh, Chin Fen ; Slavin, Monica A.

Purpose of review:

Given the high mortality and morbidity associated with invasive fungal diseases (IFDs), the use of combination antifungal therapies is often considered despite the dearth of data. This review aims to summarize the current state of literature of combination antifungal therapies, discussing the potential roles of newer antifungal combinations and key considerations for their clinical use.

Recent findings:

In infections other than cryptococcal meningitis or in the setting of empirical treatment for suspected azole-resistant Aspergillus infections, the utility of the combination antifungal approaches remains controversial given the paucity of well designed randomized controlled trials. Data on potential combined antifungal treatments have been primarily limited to in-vitro studies, animal models, case reports and/or observational studies. With availability of novel antifungal agents (e.g. ibrexafungerp, fosmanogepix), combination therapy to treat mould infections should be re-visited. A phase 2 clinical trial of ibrexafungerp combined with voriconazole to treat invasive pulmonary aspergillosis is on-going.

Summary:

There is a need to investigate the use of combination antifungal agents. This includes delineating the indication of these combined antifungal therapies and determining how to use them most appropriately in the clinical setting.

01 Dec 2024·CURRENT OPINION IN INFECTIOUS DISEASES

Update on diagnosis and treatment of fungal meningitis: lessons from recent outbreaks

Review

Author: Ostrosky-Zeichner, Luis ; Gonzalez-Lara, Maria F. ; Beltran-Reyes, Paula

Purpose of review:

Recently, fungal meningitis outbreaks have occurred in association with neuraxial and epidural anesthesia in immunocompetent patients. Herein, we describe the course of those outbreaks, their diagnosis, treatment, prognosis, and lessons learned.

Recent findings:

Two outbreaks of Fusarium solani meningitis during 2022–2023 were associated with epidural anesthesia in two distant cities in Mexico (Durango and Matamoros). The initial etiological agent identification was delayed due to insensitivity of cultures. A Fusarium solani qPCR was validated and positive in 38% cerebrospinal fluid (CSF) samples from Durango, while BD-Glucan allowed early diagnosis of the index case in Matamoros. Antifungal treatment with voriconazole and liposomal amphotericin B (L-AmB) was recommended. Overall mortality was 51%. Once the cause was confirmed, some patients received fosmanogepix.

Summary:

Fungal meningitis outbreaks due to filamentous fungi are usually associated with direct epidural inoculation. They result in severe presentations and high mortality. Early diagnosis should be suspected, BD-Glucan CSF testing screening is recommended. Aggressive antifungal treatment based on antifungal susceptibility testing should be administered as early as possible. The advent of molecular diagnostic methods and new antifungal drugs may allow for timely diagnosis and treatment, increasing the chances of survival.

News (Medical) associated with Fosmanogepix

21 Apr 2025

·www.globenewswire.com

Basilea reports presentation of new data for fosmanogepix, isavuconazole (Cresemba®) and ceftobiprole (Zevtera®) at ESCMID Global 2025

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.

Orphan DrugClinical ResultDrug ApprovalFast Track

18 Feb 2025

·www.fiercebiotech.com

Basilea opts not to take MRSA antibiotic into clinic due to \'stringent risk-return criteria\'

“This decision demonstrates that we are focused on stringent risk-return criteria when making portfolio decisions,” Basilea Pharmaceutica said.\n Basilea Pharmaceutica has cited its “stringent risk-return criteria” as a reason for not taking up its option to bring a MRSA antibiotic into clinical development.Basilea secured the license option for the endolysin antibiotic, called tonabacase, from Korea’s iNtRON Biotechnology in 2023. Basilea had been conducting a preclinical evaluation of the asset throughout 2024 ahead of a decision on whether to secure the exclusive rights to take tonabacase into human trials.When it signed the agreement with iNtRON, Basilea pointed to preclinical evidence of tonabacase’s activity against methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA and MSSA) as well as coagulase-negative staphylococci.“There continues to be a high medical need for new treatment options for patients with persistent infections caused by Gram-positive bacteria and tonabacase is an exciting and innovative asset for us to evaluate over the coming months,” Basilea Chief Medical Officer Marc Engelhardt, M.D., said back in 2023. “If the outcome of our evaluation is positive and we enter into a full license agreement, we may be able to start directly a phase 2 clinical study in 2025.” That trial is now off the menu, as Basilea has completed its own preclinical profiling of the medicine and “taken the decision not to pursue further development,” the Swiss company said in its full-year earnings report.“This decision demonstrates that we are focused on stringent risk-return criteria when making portfolio decisions,” the company added.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 last year. The company’s clinical pipeline is headed up by fosmanogepix, an antifungal licensed from Amplyx Pharmaceuticals that Basilea is planning to enter into its second phase 3 study against mold infections.Basilea’s work developing new antifungals received a significant boost last September from the U.S. Department of Health and Human Services, which signed off on up to $268 million of funding to the biopharma over more than a decade.

$Basilea opts not to take MRSA antibiotic into clinic due to \'stringent risk-return criteria\'$

License out/inPhase 3

08 Jan 2025

·www.globenewswire.com

Basilea provides portfolio update and outlook

Allschwil, Switzerland, January 08, 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, reported today on the progress of its Research & Development portfolio in 2024 and upcoming milestones. David Veitch, Chief Executive Officer, said: “We have achieved several significant milestones in 2024. We partnered with a highly committed, focused and capable company for the commercialization of our anti-MRSA antibiotic, Zevtera, in the United States, following its approval earlier in the year. For our leading antifungal Cresemba, the European Commission expanded the approved uses to include treatment for pediatric patients. This not only made Cresemba available to children, but also extended its protection from generic competition in the EU until late 2027. We are also pleased to have been awarded very significant non-dilutive funding from BARDA and CARB-X to support the development of novel, first-in-class antifungals and antibacterials within our R&D portfolio. Finally, we laid the foundation for future growth by commencing a phase 3 study in invasive yeast infections with our potential next lead product, the broad-spectrum antifungal fosmanogepix. Throughout 2025, we aim to continue both progressing our current R&D assets and expanding our portfolio through targeted in-licensing and acquisition of innovative, commercially attractive, pre-clinical and clinical assets, addressing unmet medical needs in the treatment of severe fungal and bacterial diseases.” Maintaining its strong momentum, the commercial performance of Cresemba triggered several milestone payments to Basilea in 2024. By year-end 2024, Cresemba was marketed in more than 70 countries, including the United States (US), most EU member states, China and Japan. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between October 2023 and September 2024 amounted to USD 533 million, a 20 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.1 Portfolio key highlights 2024 and outlook 2025 Cresemba® (isavuconazole): Indications expanded to pediatric patients In August, the European Commission approved the use of Cresemba in children with invasive aspergillosis or mucormycosis,2 following a similar decision by the US Food and Drug Administration (FDA) in December 2023; the market exclusivity of Cresemba was extended to October 2027 in the EU and September 2027 in the US. Zevtera® (ceftobiprole): US approval and commercialization progress; Chinese NRDL inclusion In April, the US FDA approved Zevtera for SAB, ABSSSI and CABP, i.e. all three submitted indications.3, 4In September, Zevtera has been approved for New-Technology Add-On Payment (NTAP) in the US, which will provide hospitals an incremental payment in addition to standard reimbursement, by the Centers for Medicare & Medicaid Service (CMS).5In December, we announced Innoviva Specialty Therapeutics (IST) as commercialization partner for the US market. The US launch is expected mid-2025.In China, ceftobiprole (Chinese trade name: Sibipre®) has been included in the National Reimbursement Drug List (NRDL) at the end of 2024, making it eligible for reimbursement under the Chinese national basic medical insurance program from 2025. Clinical and preclinical pipeline: Substantial progress made and significant funding secured The “Other Transaction Agreement” (OTA)6 with the Biomedical Advanced Research and Development Authority (BARDA) signed in September provides up to approximately USD 268 million non-dilutive funding over up to 12 years for the development of novel antifungals and antibacterials. An initial commitment of USD 29 million supports the development of our antifungals fosmanogepix and BAL2062.In September, we commenced a phase 3 study with fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis, i.e. severe invasive yeast infections. A second phase 3 study, in invasive mold infections, is expected to start in the coming months.The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) awarded non-dilutive funding of USD 7.3 million in December for the first-in-class LptA inhibitor antibiotic, BAL2420, which we acquired in January 2024.7 This was new funding on top of USD 0.9 million awarded in April. The extended funding supports the progression of the drug candidate towards a first-in-human clinical study which is expected to start mid-2026. BAL2420 is being developed for the potential treatment of severe infections caused by Gram-negative bacteria.Preclinical evaluations for the antibacterial tonabacase and the antifungal BAL2062 are well advanced. We expect to take the decision whether to exercise our option to initiate exclusive contract negotiations to license tonabacase for further clinical development and commercialization in the next few weeks. For BAL2062, our focus in 2025 will be on the completion of the preclinical profiling and the preparation of the phase 2 program so that we can start the clinical study in early 2026. 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. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland 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 IQVIA Analytics Link, September 2024. In-market sales reported as moving annual total (MAT) in US dollar.European Public Assessment Report (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: January 07, 2025]Full US prescribing information: https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk; SAB: Staphylococcus aureus bacteremia; ABSSSI: Acute bacterial skin and skin structure infections; CABP: Community-acquired bacterial pneumonia.Basilea’s ceftobiprole phase 3 program is funded in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C. Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the Staphylococcus aureus bacteremia (SAB) and acute bacterial skin and skin structure infections (ABSSSI) phase 3 studies, regulatory activities and non-clinical workDepartment of Health and Human Services, Centers for Medicare & Medicaid Services: Medicare and Medicaid Programs and the Children's Health Insurance Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other Policy Changes: https://federalregister.gov/d/2024-17021 (Accessed: January 07, 2025)BARDA OTA number: 75A50124C00033CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; Antibacterials branch; under agreement number 75A50122C00028; and by awards from Wellcome (WT224842) and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. Attachment 20250108_Basilea Press release_Portfolio status update_EN.pdf

Drug ApprovalPhase 3License out/in

100 Deals associated with Fosmanogepix

External Link

KEGG	Wiki	ATC	Drug Bank
D11694	-	-	DB15183

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Candidiasis, Invasive	Phase 3	-	Basilea Pharmaceutica AG	23 Aug 2024
Candidemia	Phase 3	-	Pfizer Inc.	05 Dec 2022
Invasive aspergillosis	Phase 2	United States	Basilea Pharmaceutica AG	04 Jan 2020
Invasive aspergillosis	Phase 2	Belgium	Basilea Pharmaceutica AG	04 Jan 2020
Invasive aspergillosis	Phase 2	Germany	Basilea Pharmaceutica AG	04 Jan 2020
Invasive aspergillosis	Phase 2	Israel	Basilea Pharmaceutica AG	04 Jan 2020
Candida Auris Infection	Phase 2	South Africa	Basilea Pharmaceutica AG	13 Dec 2019
Liver Injury	Phase 1	United States	Pfizer Inc.	31 Oct 2022
Liver Injury	Phase 1	United States	Basilea Pharmaceutica AG	31 Oct 2022
Acute Myeloid Leukemia	Phase 1	Germany	Basilea Pharmaceutica AG	27 Nov 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04240886 (AEGIS, Pubmed \| Clin Infect Dis)	Phase 2	Invasive aspergillosis \| Invasive Fungal Infections	21	Fosmanogepix 1000 mg IV	tpfuqkdzhr(fyozkgrgge) = 258 adverse events (AEs) were reported (n=21) dccqpllfyp (qchgaltzzm ) View more	Positive	09 Apr 2025
NCT04804059 (Pubmed) Manual	Phase 1	-	10	Fosmanogepix 500 mg oral	udofdhrpqw(rezmwnkzjh) = pxthdiwwfy qsplkmtryt (yfvbqizecm )	Positive	16 Jul 2024
NCT04804059 (Pubmed) Manual	Phase 1	-	10	Fosmanogepix 600 mg IV	udofdhrpqw(rezmwnkzjh) = nplnmdewnp qsplkmtryt (yfvbqizecm )	Positive	16 Jul 2024
NCT04148287 (Pubmed) Manual	Phase 2	Candidemia	9	Fosmanogepix	drknqnezfd(mxajkpdnbv) = uwfserggnz eqwwzvgyux (vijxjuszwf ) View more	Positive	06 Apr 2023
NCT02957929 \| NCT02956499 (Pubmed) Manual	Phase 1	Invasive Fungal Infections	154	Fosmanogepix	ujxlssfobp(ircxfqqhbi) = grzpjrersv txfihvdznu (cclsmxktwa ) View more	Positive	29 Mar 2023
NCT02957929 \| NCT02956499 (Pubmed) Manual	Phase 1	Invasive Fungal Infections	154	placebo	-	Positive	29 Mar 2023
NCT04148287 (APEX, CTgov)	Phase 2	Candida Auris Infection \| Candidemia	9	APX001 (Fosmanogepix)	ciabdgkmdz = iwgamhyvfi tzkxrmunku (jemuuhpyxy, otkzuqcmpu - fathakehud) View more	-	09 Jan 2023
NCT03604705 (PipelineReview) Manual	Phase 2	Candidemia First line	21	Fosmanogepix	ndocprnwrq(mjrkbwqidq) = toydoirryp xckirhzfpp (wtldsvekne ) View more	Positive	20 Jul 2020

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Approval

Accelerate your research with the latest regulatory approval information.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis