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.

开始日期2025-08-26

申办/合作机构

Basilea Pharmaceutica AG

[+1]

NCT06961708

/ Completed临床1期

A Phase 1, Randomized, Single-center, Double-blind, Placebo-controlled Study of Fosmanogepix Administered as Single and Multiple Doses in Healthy Adult Chinese Subjects

The purpose of this study is to investigate the pharmacokinetics and safety of the investigational drug fosmanogepix including its active moiety manogepix following a single dose and multiple doses (by intravenous infusion (IV) or orally) in healthy Chinese adults.
The study consists of 2 consecutive Parts (Part-1, single-dose part followed by Part-2, multiple-dose part) including a total of approximately 52 participants.
Part-1 duration will be up to 64 days including 4 visits at the clinical site and Part-2 duration will be up to 70 days including 5 visits at the clinical site. The study will include a total of 4 study sub-groups (Cohorts 1-4) in which fosmanogepix or placebo will be administered in different strengths orally or IV.
Participants will be enrolled and randomly assigned to study drug.
During the study, 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.
All data analyses will be descriptive (no statistical analysis will be provided).

开始日期2025-04-14

申办/合作机构

Basilea Pharmaceutica AG

[+1]

NCT05421858

/ Recruiting临床3期

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.

开始日期2024-12-11

申办/合作机构

Basilea Pharmaceutica AG

[+1]

100 项与 Fosmanogepix 相关的临床结果

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100 项与 Fosmanogepix 相关的转化医学

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100 项与 Fosmanogepix 相关的专利（医药）

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项与 Fosmanogepix 相关的文献（医药）

2025-09-01·BRAZILIAN JOURNAL OF MICROBIOLOGY

In vitro effects of the new antifungal compound manogepix (APX001) against the three most clinically relevant species of Sporothrix

Article

作者: Almeida-Paes, Rodrigo ; Zancopé-Oliveira, Rosely Maria ; Poester, Vanice Rodrigues ; Tenório-Alvarenga, Pedro Henrique ; Marques, Fernanda Praça Nogueira ; Xavier, Melissa Orzechowski ; Almeida-Silva, Fernando

Sporotrichosis is an endemic mycosis that pose significant public health challenges, particularly in Brazil, where zoonotic transmission has increased the number of cases in several regions of the country. The disease is caused by Sporothrix genus, with S. brasiliensis, S. schenckii, and S. globosa as the major agents. The currently available therapies may face limitations such as varying cure rates, long and expensive treatment, and adverse effects. Fosmanogepix, a prodrug converted into manogepix within the host, has demonstrated broad-spectrum antifungal activity, including other thermodimorphic fungal species. Thus, this study aimed to evaluate the in vitro antifungal efficacy of manogepix against three clinically relevant Sporothrix species. Minimal inhibitory and fungicidal concentrations were determined against 24 Sporothrix spp. isolates, as well as potential synergism with antifungal drugs, induction of resistance and growth kinetics of the fungus in the presence of the new antifungal drug. Manogepix exhibited fungicidal activity against the three Sporothrix species tested, with minimum inhibitory concentrations (MIC) ranging from 0.06 to 1 µg/ml. Furthermore, manogepix demonstrated a lower geometric mean of MIC values compared to the antifungal drugs and indifferent interactions with itraconazole, terbinafine and amphotericin B. Prolonged exposure to subinhibitory manogepix concentrations did not induce resistance in the tested strains. These findings indicate manogepix as a promising candidate for the treatment of sporotrichosis, offering a potential alternative in cases of resistance or treatment failure with current antifungals. Further studies are needed to confirm this activity in clinical settings, particularly in diverse geographic regions and against a broader range of Sporothrix strains.

2025-08-11·Future Microbiology

Clinical impact of fluconazole-resistant Candida parapsilosis: a narrative review.

Review

作者: Bassetti, Matteo ; Vena, Antonio ; Giacobbe, Daniele Roberto ; Bartalucci, Claudia

Fluconazole resistance in Candida parapsilosis is an increasing global concern, with resistance rates varying widely and reaching up to 80% in some regions. This trend has led to hospital outbreaks, primarily driven by mutations in the ERG11 gene, especially the Y132F substitution. The clinical relevance of fluconazole resistance remains controversial, as studies have yielded conflicting results regarding its impact on mortality. While some studies described an increased mortality associated with resistant strains, others reported no significant difference. Treatment options are limited: echinocandins and liposomal amphotericin B (L-AmB) are commonly used alternatives, but their use is challenged by intrinsic and emerging echinocandin resistance and L-AmB toxicity and cost. These limitations emphasize the need for robust antifungal stewardship and the development of new therapies. Novel agents such as rezafungin, fosmanogepix, and ibrexafungerp have shown promising activity against fluconazole-resistant C. parapsilosis, though further clinical studies are needed to confirm their efficacy. This narrative review aims to summarize current evidence on the epidemiology, clinical implications, and therapeutic approaches for fluconazole-resistant C. parapsilosis infections.

2025-07-11·Cureus Journal of Medical Science

Disseminated Musculoskeletal Coccidioidomycosis in an Immunocompetent Host: A Rare Case Requiring Extensive Spinal and Pelvic Surgery

Article

作者: Raman, Elangovan ; Sharma, Sorabh

Coccidioidomycosis, also known as "Valley Fever," is an endemic fungal infection caused by Coccidioides species, typically presenting as a respiratory illness. Disseminated disease, particularly with extensive skeletal involvement, is rare and typically seen in immunocompromised individuals. We report a unique and severe case of disseminated musculoskeletal coccidioidomycosis in a previously healthy immunocompetent 33-year-old African American man, involving multiple spinal levels, pelvic bones, and the right chest wall. The patient required multiple orthopedic surgeries, including anterior and posterior spinal decompression and fusion, bilateral sacroiliac joint debridement, and pelvic fixation. The diagnosis was confirmed via bone biopsy demonstrating Coccidioides spherules. Despite antifungal therapy, his disease progressed, necessitating escalation of treatment from fluconazole to isavuconazole and liposomal amphotericin B, followed by initiation of fosmanogepix as part of the approved treatment regimen. This case highlights the importance of high clinical suspicion, aggressive surgical intervention, and multidisciplinary management in complex disseminated coccidioidomycosis, even in immunocompetent hosts.

项与 Fosmanogepix 相关的新闻（医药）

2025-08-19

·GlobeNewswire-Health Care

Basilea on track with strong 2025 half-year results

Cresemba® and Zevtera®-related revenues rise by 24% to CHF 90.5 millionTotal revenue grows significantly by 36% to CHF 104.0 millionOperating profit surges by 160% to CHF 24.0 millionOperating cash flow increases by 29% to CHF 23.1 millionFull-year 2025 guidance: on track and updated to reflect recent in-licensing of a novel oral phase 3-ready antibiotic Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, August 19, 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 its results for the first half-year ended June 30, 2025. David Veitch, Chief Executive Officer, stated: “The first half of 2025 has marked a period of strong execution and meaningful progress across both the antibacterial and antifungal parts of our portfolio. The launch of Zevtera in the US, its most important commercial market, is a major milestone and represents a pivotal moment in the brand’s history. On the antifungal side, we have seen encouraging momentum from our global commercial partnerships, including the first milestone payments for Cresemba sales in Japan. A further highlight was the release of another USD 39 million from BARDA to support the ongoing development of fosmanogepix and BAL2062. The recent start of a phase 3 clinical study for fosmanogepix in invasive mold infections, conducted in parallel with the ongoing phase 3 study in invasive yeast infections provides strong evidence of the clinical progress we are making. Our stated goal to deliver new treatment options for patients with life-threatening fungal infections is becoming reality. Furthermore, the agreement we just announced to acquire the global rights to a novel oral phase 3-ready antibiotic for the treatment of complicated urinary tract infections, marks yet another strategic milestone to strengthen our late-stage clinical pipeline with innovative assets.” Adesh Kaul, Chief Financial Officer, said: “We are reporting another period of strong financial performance, with increasing revenues, operating profits and operating cash flows. We expect continued strong in-market sales growth, which will result in increasing royalty revenue and milestone payments in the second half of this year. We strengthened our balance sheet by reducing the outstanding value of our convertible bonds by 14% to CHF 83 million in nominal value, while at the same time increasing our cash position. Our strong financial position demonstrates the robustness of our unique business model and enables us to continue investing in the expansion of our pipeline.” Financial summary For the first half year (H1) 2025, Basilea recognized total revenue of CHF 104.0 million (H1 2024: CHF 76.3 million), an increase of 36.3% year-on-year. This included royalty income of CHF 52.1 million (H1 2024: CHF 42.8 million), which increased by 21.7% year-on-year, and product revenue of CHF 31.5 million (H1 2024: CHF 27.6 million). Milestone and upfront payments have also increased to CHF 6.9 million (H1 2024: CHF 2.9 million). Other revenue amounted to CHF 13.5 million (H1 2024: CHF 3.0 million). This included CHF 11.1 million BARDA[1] reimbursements (H1 2024: CHF 2.0 million) and CHF 1.9 million CARB-X[2] funding (H1 2024: CHF 0.6 million). BARDA reimbursements were for activities related to the fosmanogepix phase 3 program, the antifungal BAL2062, and ceftobiprole, while CARB-X funding supports preclinical activities related to the antibiotic BAL2420. In H1 2025, Basilea invested CHF 38.3 million (H1 2024: CHF 33.6 million) in research and development (R&D), mainly related to the ongoing phase 3 clinical study of fosmanogepix in invasive yeast infections, the preparations for starting a second phase 3 clinical study with fosmanogepix in invasive mold infections, the preclinical profiling of BAL2062 and BAL2420 (the LptA inhibitor program), and for research work on compounds in the Company’s early-stage portfolio. Selling, general and administrative expenses, including costs for the commercialization of Cresemba and Zevtera, amounted to CHF 17.4 million (H1 2024: CHF 15.3 million) and cost of products sold increased to CHF 24.2 million (H1 2024: CHF 18.1 million), reflecting the increase in product revenue. Basilea recorded an operating result of CHF 24.0 million (H1 2024: CHF 9.3 million). In H1 2025, Basilea reported income tax expense of CHF 3.5 million (H1 2024: CHF 13.4 million income tax benefit due to the one-time effect from releasing the deferred tax asset valuation allowance) and a net profit of CHF 15.8 million (H1 2024: CHF 20.7 million), resulting in a basic and diluted earnings per share of CHF 1.29 and CHF 1.26, respectively (H1 2024: basic and diluted earnings per share CHF 1.72 and CHF 1.61, respectively). In H1 2025, a positive net cash flow of CHF 23.1 million was provided by operating activities (H1 2024: CHF 17.9 million). The Company also repurchased senior unsecured convertible bonds due July 2027 in the amount of CHF 14.3 million nominal value out of a total CHF 97.1 million nominal value. Cash and cash equivalents and restricted cash amounted to CHF 132.7 million as of June 30, 2025 (June 30, 2024: CHF 69.5 million). Basilea has reduced its total financial debt by approximately CHF 138 million since the beginning of 2022 and increased its net cash position to CHF 50.7 million as of June 30, 2025 (June 30, 2024: net debt of CHF 26.2 million). Key financial figures (In CHF million, except per share data)H1 2025H1 2024 Product revenue31.527.6 Contract revenue59.045.7 Other revenue13.53.0Total revenue 104.076.3 Cost of products sold(24.2)(18.1) Research & development expenses, net(38.3)(33.6) Selling, general & administrative expenses(17.4)(15.3)Total cost and operating expenses (79.9)(67.0)Operating result24.09.3Profit before taxes19.37.3 Income taxes(3.5)13.4Net profit15.820.7Net cash provided by operating activities23.117.9Basic earnings per share, in CHF1.291.72Diluted earnings per share, in CHF1.261.61 (in CHF million)June 30, 2025June 30, 2024Cash and cash equivalents and restricted cash132.769.5 Note: Consolidated figures in conformity with US GAAP; rounding was applied consistently. The unaudited, condensed consolidated interim financial statements of Basilea Pharmaceutica Ltd, Allschwil for the first half year 2025 can be found on the company’s website at https://www.basilea.com/financial-reports. Updating 2025 financial guidance – expecting higher total revenue and reflecting recent in-licensing of a novel oral phase 3-ready antibiotic Basilea provides the following guidance for the full year (FY) 2025: Total revenue is expected to increase by 8% to CHF 225 million Basilea can offset the impact of the strengthening of the Swiss Franc and the previously announced decrease in product supply to Pfizer on Cresemba & Zevtera-related revenue.The expected 14% increase in royalty income to CHF 110 million reflects primarily the continued strong double-digit sales growth of Cresemba in its key markets.Following a year of exceptionally high milestone payments in 2024, milestone and upfront payments in 2025 are expected to remain at the level of prior years of around CHF 32 million, despite being impacted by the strengthening of the Swiss Franc, primarily versus the US Dollar.The increase in BARDA and CARB-X reimbursements is reflecting the significant operational progress with fosmanogepix, BAL2062 and BAL2420. The increase in cost and operating expenses reflects the expected impact of the recent strategic addition of ceftibuten-ledaborbactam to our late-stage clinical pipeline and our continued investment in progressing our exciting R&D portfolio of first-in-class antifungals and antibacterials. Nevertheless, we expect to maintain a high operating profit level of CHF 50 million in 2025.We expect no material cash outflow related to income taxes as a result of the use of tax loss carry forwards, but a 10.7% income tax expense will be reflected in the 2025 net profit, in contrast to a CHF 17.3 million one-time income tax benefit from releasing the deferred tax valuation allowance in 2024. (in CHF million)FY 2025enewFY 2025epreviousFY 2024 Cresemba and Zevtera-related revenue~190~190194.9 of which royalty income~110~11096.7Total revenue ~225~220208.5Research & development expenses, net~105~8877.1Operating result~50~6261.2 Conference call and webcast Basilea Pharmaceutica Ltd, Allschwil will host a conference call and webcast today, Tuesday, August 19, 2025, at 4 p.m. (CEST), to discuss the company’s financial and operating results and to provide an outlook. Via audio webcast with presentation The live audio webcast of the results presentation can be followed here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=AAxPAsgp. Please note that there is no function to ask questions via webcast. For questions, please additionally dial-in via phone (see below). Via phone To listen by phone and ask questions, please use the dial-in details below. To ensure prompt access, please call approximately five minutes prior to the scheduled start of the call. +41 (0) 58 310 5000(Switzerland, Europe and RoW)+1 (1) 866 291 4166 (USA)+44 (0) 207 107 0613(UK) Replay The webcast, along with the presentation will be available online (same link as live audio webcast above) shortly after the event and accessible for three months. 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, PhDHead of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone+41 61 606 1102 E-mailmedia_relations@basilea.cominvestor_relations@basilea.com This ad hoc announcement can be downloaded from www.basilea.com. References The Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS), provided partial funding for Basilea’s ceftobiprole Phase 3 program under contract number HHSO100201600002C. This funding covered approximately USD 111 million, or about 75% of the costs for the Staphylococcus aureus bacteremia (SAB) and acute bacterial skin and skin structure infections (ABSSSI) Phase 3 studies, regulatory activities, and non-clinical work. BARDA is also supporting Basilea’s fosmanogepix and BAL2062 programs under OTA number 75A50124C00033. CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) funding for this project is provided in part by 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). Attachment Press release (PDF).pdf

临床3期财报引进/卖出

2025-07-29

·GlobeNewswire-Health Care

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

Study to evaluate the efficacy and safety of fosmanogepix in adults with invasive mold infectionsStudy 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. 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 FORWARD-IM (FOsmanogepix study Run Worldwide as Antifungal treatment in Resistant Disease caused by Invasive Molds): ClinicalTrials.gov identifier: NCT06925321K. 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), 239M. 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), e01623-22J. 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), e01419-22P. 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), 2471-2480M.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:ciaf185FAST-IC (Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis): ClinicalTrials.gov identifier: NCT05421858J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434M. 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.e10Candidemia (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)B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456 Attachment Press release (PDF)

临床2期临床3期快速通道孤儿药合格传染病产品

2025-07-08

·EndPoints

Recursion takes full rights to rare genetic disorder drug; CStone out-licenses cancer drug in Europe

Plus, news about Basilea, BARDA, Inventiva and CTTQ: Recursion buys full rights to oral drug: The AI-driven biotech, which recently restructured , acquired the full rights to REV102, an oral ENPP1 inhibitor, from Rallybio. The companies had a joint venture on REV102, which is intended for a rare genetic disorder known as hypophosphatasia. The drug is slated to enter Phase 1 in the second half of next year. Recursion will pay $7.5 million in upfront equity , another $12.5 million equity payment once more preclinical studies begin and $5 million once the Phase 1 trial begins dosing participants. — Kyle LaHucik CStone out-licenses sugemalimab for up to $192.5M: Istituto Gentili will get commercial rights for the PD-L1 targeting drug in 23 European countries as well as the UK, Andorra, Monaco, San Marino and Vatican City. The deal value consists of both upfront and milestone payments. CStone is also eligible for almost half the revenues from the licensed territories. Sugemalimab is approved in Europe and the UK for metastatic non-small cell lung cancer. — Ayisha Sharma Basilea secures more BARDA funding for antifungals: The US government agency is handing over $39 million as part of a multi-year agreement inked with Basilea last year. The agreement focuses in part on the development of two antifungal drugs called fosmanogepix and BAL2062. Basilea could get up to $268 million in total. — Ayisha Sharma Inventiva gets $10M milestone from CTTQ: The milestone payment follows from a licensing deal inked in 2022. As part of that agreement, CTTQ got development and commercialization rights for Inventiva’s MASH drug, lanifibranor, in China and several other Asian markets. Inventiva is eligible for up to $290 million in milestones. — Ayisha Sharma

引进/卖出上市批准临床1期抗体药物偶联物

100 项与 Fosmanogepix 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11694	-	-	DB15183

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
侵袭性曲霉菌病	临床3期	美国	Basilea Pharmaceutica AG	2025-07-01
毛霉菌病	临床3期	美国	Basilea Pharmaceutica AG	2025-07-01
侵袭性念珠菌病	临床3期	-	Basilea Pharmaceutica AG	2024-08-23
念珠菌血症	临床3期	-	Pfizer Inc.	2022-12-05
耳念珠菌感染	临床2期	南非	Basilea Pharmaceutica AG	2019-12-13
肝损伤	临床1期	美国	Pfizer Inc.	2022-10-31
肝损伤	临床1期	美国	Basilea Pharmaceutica AG	2022-10-31
急性髓性白血病	临床1期	德国	Basilea Pharmaceutica AG	2017-11-27
中性粒细胞减少	临床1期	德国	Basilea Pharmaceutica AG	2017-11-27
真菌病	临床1期	荷兰	Basilea Pharmaceutica AG	2016-05-24

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04240886 (AEGIS, Pubmed \| Clin Infect Dis)	临床2期	侵袭性真菌感染	21	Fosmanogepix 1000 mg IV	壓範淵廠遞繭獵衊餘齋(獵襯糧憲糧鏇醖願醖鬱) = 258 adverse events (AEs) were reported (n=21) 膚網壓窪鹹積淵鑰餘廠 (餘願淵襯顧衊遞鏇鬱憲 ) 更多	积极	2025-04-09
NCT04804059 (Pubmed) 人工标引	临床1期	-	10	Fosmanogepix 500 mg oral	遞齋憲製醖積廠膚製鹽(夢觸構夢製構蓋願艱鹹) = 製鑰膚醖壓鏇繭蓋糧遞鹹窪選築糧蓋範糧壓簾 (窪餘觸膚製窪顧夢壓齋 )	积极	2024-07-16
NCT04804059 (Pubmed) 人工标引	临床1期	-	10	Fosmanogepix 600 mg IV	遞齋憲製醖積廠膚製鹽(夢觸構夢製構蓋願艱鹹) = 襯鬱鑰廠衊衊積製蓋網鹹窪選築糧蓋範糧壓簾 (窪餘觸膚製窪顧夢壓齋 )	积极	2024-07-16
NCT04148287 (Pubmed) 人工标引	临床2期	念珠菌血症	9	Fosmanogepix	糧積築窪壓積顧廠積鬱(夢繭蓋憲蓋蓋鑰淵糧糧) = 顧鹹網鹽顧膚廠鹹簾範壓醖襯醖餘觸網窪鏇膚 (築構網艱範醖繭廠鹹製 ) 更多	积极	2023-04-06
NCT02957929 \| NCT02956499 (Pubmed) 人工标引	临床1期	侵袭性真菌感染	154	Fosmanogepix	範網襯願鹹糧鑰憲範醖(鏇窪襯艱製齋鑰襯淵齋) = 範繭夢襯鑰壓齋網襯顧鏇餘鬱構製膚淵遞餘淵 (艱顧鹹願醖構顧構構範 ) 更多	积极	2023-03-29
NCT02957929 \| NCT02956499 (Pubmed) 人工标引	临床1期	侵袭性真菌感染	154	placebo	-	积极	2023-03-29
NCT04148287 (APEX, CTgov)	临床2期	耳念珠菌感染 \| 念珠菌血症	9	APX001 (Fosmanogepix)	繭艱觸顧餘鹽繭獵願觸 = 願鹹餘齋繭憲憲廠觸艱鑰醖製膚選衊繭餘壓窪 (鬱衊範網夢範夢糧構構, 鹹繭鹽醖廠艱鹽願夢繭 ~ 鏇鹽繭膚蓋齋膚糧壓壓) 更多	-	2023-01-09
NCT03604705 (PipelineReview) 人工标引	临床2期	念珠菌血症一线	21	Fosmanogepix	蓋艱艱齋醖廠憲網鏇觸(醖艱築夢鏇艱鹽窪網鏇) = 築鬱醖廠鹽製糧糧醖窪鹽憲廠鬱齋淵構糧齋膚 (製網選獵衊願夢艱鏇膚 ) 更多	积极	2020-07-20