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]

NCT05582187

/ Recruiting临床1期

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.

开始日期2022-10-31

申办/合作机构

Basilea Pharmaceutica AG

[+1]

NCT05491733

/ Completed临床1期

A 3-Treatment, 3-Period, 6-Sequence Randomized Crossover Single-Dose Study Evaluating the Bioequivalence of High-Load and Low-Load Oral Tablet Formulations of Apx001 and the Effect of Food on the Absorption of Apx001 From the High-Load Tablet In Healthy Subjects

A study to learn about the bioequivalence (the biochemical similarity of two medicines that share the same active ingredient and desired outcome for patients) of the study medicine called APX001 in healthy participants.

开始日期2021-03-02

申办/合作机构

Basilea Pharmaceutica AG

100 项与 Fosmanogepix 相关的临床结果

登录后查看更多信息

100 项与 Fosmanogepix 相关的转化医学

登录后查看更多信息

100 项与 Fosmanogepix 相关的专利（医药）

登录后查看更多信息

项与 Fosmanogepix 相关的文献（医药）

2024-12-01·CURRENT OPINION IN INFECTIOUS DISEASES

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

Review

作者: 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.

2024-12-01·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

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

Article

作者: 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.

2024-12-01·CURRENT OPINION IN INFECTIOUS DISEASES

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

Review

作者: 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.

项与 Fosmanogepix 相关的新闻（医药）

2025-01-08

·GlobeNewswire-Health Care

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

上市批准临床3期引进/卖出

2024-11-29

·凯莱英药闻

本周国内新药里程碑汇总：2款国产ADC获批上市

欢迎关注凯莱英药闻（收集周期：11.25-11.29，国内部分为首次申请临床、首次申请上市、首次批准上市的创新药）国内创新药IND汇总 1、Basilea：Fosmanogepix片/注射液作用机制：GWT1抑制剂适应症：真菌感染 11月26日，Basilea的fosmanogepix片/注射液的临床试验申请获CDE受理。Fosmanogepix可抑制真菌糖基磷脂酰肌醇（GPI）锚定蛋白转移1（Gwt1）基因，对多种病原真菌具有广谱活性；对念珠菌属（除克柔念珠菌）、耳念珠菌、新型隐球菌、粗球孢子菌具有较强的体外抗菌活性，尤其是耐氟康唑耳念珠菌。该药物可以静脉或口服给药，口服生物利用度>90%，与食物同时服用不会改变。该药具有较长的半衰期(2.5天)和良好的组织分布，包括在脑和眼部。2021年4月，辉瑞收购Amplyx获得fosmanogepix (APX001)的开发权；2024年1月，辉瑞终止该药物的一项2期多中心研究，旨在评估APX001用于治疗由曲霉菌属或罕见霉菌引起的侵袭性真菌感染，优先进行同一适应症的随机对照 3期试验。该药物与脂质体两性霉素B（LAmB）的协同作用为难治性感染治疗开辟了新途径。 2、多域生物：HPB-143片作用机制：靶向IRAK4 PROTAC 适应症：特应性皮炎 11月26日，多域生物的HPB-143片的临床试验申请获CDE受理。HPB-143是一款靶向IRAK4的PROTAC，临床前试验展示出蛋白降解效果和激酶选择性，具有良好的药代动力学特征，以及动物模型中明确的药效与可控的安全性，具有“同类最佳”开发潜力。具体包括：（1）相比于KT-474拥有更强的蛋白降解效果；（2）具有49％的口服生物利用度；（3）在人体内具有更优的安全性；其中HPB-143对hERG没有抑制（IC50＞10μM）,而KT-474对hERG有一定的抑制活性（IC50为0.36μM）。4)在平行比较的多个动物药效实验中，HPB-143相比于KT-474起效剂量更低。 3、韩美制药：Eflapegrastim注射液作用机制：粒细胞集落刺激因子适应症：中性粒细胞减少症 11月28日，韩美的Eflapegrastim注射液的临床试验申请获CDE受理。Eflapegrastim是一种长效的粒细胞集落刺激因子，通过结合在粒细胞祖细胞上表达的G-CSF受体来刺激其增殖过程，使其最终在骨髓中产生功能性活化的嗜中性粒细胞。该药物于2022年9月获FDA批准用于降低发热性中性粒细胞减少症患者的感染风险。3期临床试验显示，eflapegrastim能够缩短化疗诱导的重度中性粒细胞减少症持续时间，使罹患重度中性粒细胞减少症的绝对风险降低了8.5%。此外，与活性对照药物具有相似的安全性。国内创新药NDA汇总 1、艾伯维/诺华：盐酸阿曲生坦片作用机制：ERA拮抗剂适应症：原发性免疫球蛋白A肾病 11月26日，艾伯维和诺华共同开发的盐酸阿曲生坦片的上市申请获CDE受理。阿曲生坦（Atrasentan）是一款口服、小分子类型的内皮素血管紧张素受体拮抗剂，作用于ETA 靶点；通过阻断肾小球系膜细胞活化，直接的抗炎和抗纤维化，降低球囊内压力和肾小球滤过屏障大分子通透性来减少免疫球蛋白A肾病(IgAN) 患者的尿蛋白。一项随机、双盲、安慰剂对照、平行组研究的临床3 期ALIGN试验，340 例IgA肾病患者在目前标准的支持治疗（最大耐受剂量RAS 抑制剂）基础上接受每日一片0.75mg 的Atrasentan 或安慰剂治疗132 周（约2.5 年），主要终点是第36周时24 小时UPCR 较基线的变动比例，次要终点132 周期间eGFR 的时间加权平均变化等数据，中期分析数据显示，第36 周时24 小时UPCR 较安慰剂下降36.1%（P<0.0001）。该研究将继续在136 周内通过估计的肾小球滤过率(eGFR)测量肾功能变化，顶线结果计划将于 2026 年第一季度公布。 2、艺妙神州/华东医药：IM19嵌合抗原受体T细胞注射液作用机制：靶向CD19 CAR-T 适应症：弥漫性大B细胞淋巴瘤 11月28日，艺妙神州的IM19嵌合抗原受体T细胞注射液的上市申请获CDE受理。IM19是一种自体CD19靶向CAR-T细胞产品，通过慢病毒转导T细胞产生。2024年8月，艺妙神州与华东医药就IM19在中国大陆地区达成商业化授权合作。该药物上市许可申请的受理是基于一项在中国进行的开放标签、单臂、多中心I/II期的临床试验，结果显示，IM19 CAR-T细胞注射液针对复发或难治CD19阳性的非霍奇金淋巴瘤，具有良好的疗效和安全性。国内创新药上市获批 1、科伦博泰：注射用芦康沙妥珠单抗作用机制：靶向TROP2 ADC 适应症：三阴性乳腺癌 11月27日，科伦博泰的注射用芦康沙妥珠单抗获NMPA批准上市，用于既往至少接受过2种系统治疗（其中至少1种治疗针对晚期或转移性阶段）的不可切除的局部晚期或转移性三阴性乳腺癌成人患者。芦康沙妥珠单抗（sac-TMT）是一种靶向人滋养细胞表面抗原2（TROP2）的ADC，通过重组抗TROP2人源化单克隆抗体特异性识别肿瘤细胞表面的TROP2，并被肿瘤细胞内吞，在细胞内释放小分子化合物，诱导肿瘤细胞发生周期阻滞和凋亡。在OptiTROP-Breast01 III期临床中，将芦康沙妥珠单抗与化疗对比治疗转移性三阴性乳腺癌（TNBC）；根据盲态独立评审委员会（BICR）的评估结果，结果显示：（1）芦康沙妥珠单抗组中位PFS为6.7个月，化疗组为2.5个月，相比化疗发生疾病进展或死亡的风险降低68%。（2）芦康沙妥珠单抗组在各亚组中PFS均显著延长，与总体人群获益一致。在TROP2高表达（H评分>200）的患者中观察到更好的PFS获益趋势，sac-TMT组和化疗组的中位PFS分别为8.3和2.3个月。（3）Sac-TMT组的中位OS尚未达到，化疗组的中位OS为9.4个月；HR为0.53（P=0.0005），sac-TMT相比化疗发生死亡的风险降低47%。 2、华东医药：索米妥昔单抗注射液作用机制：靶向FRα ADC 适应症：卵巢癌 11月27日，华东医药的索米妥昔单抗注射液获NMPA批准上市，用于既往接受过1-3线系统性治疗的叶酸受体α阳性的铂类耐药卵巢癌（PROC）。索米妥昔单抗为中美华东与ImmunoGen目前已被AbbVie收购）合作开发的靶向叶酸受体α（FRα）ADC药物，由FRα结合抗体、可裂解的连接子和美登木素生物碱DM4组成；2022年11月，该药物获FDA加速批准上市，是美国FDA批准的首个用于铂耐药卵巢癌的ADC药物，适应症为既往接受过1-3种系统治疗的叶酸受体α（FRα）阳性的铂类耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌成年患者。本次获批主要基于一项国际多中心Ⅲ期研究和一项评价中国成人患者中的安全性、耐受性和药代动力学的Ⅰ期研究，另一项中国关键性单臂临床试验也于2021年8月获得NMPA批准。2023年7月，索米妥昔单抗注射液已被国家药品监督管理局药品审评中心（CDE）纳入优先审评品种名单。 3、华东医药：注射用利纳西普作用机制：IL-1R融合蛋白适应症：冷吡啉相关周期性综合征 11月27日，华东医药的注射用利纳西普获NMPA批准上市，用于治疗成人和12岁及以上青少年冷吡啉相关周期性综合征（CAPS），包括家族性寒冷性自身炎症综合征（FCAS）和Muckle-Wells综合征（MWS）。利纳西普是重组二聚体融合蛋白，可阻断白细胞介素-1α（IL-1α）和白细胞介素-1β（IL-1β）的信号传导。该药物（商品名：ARCALYST）最早由再生元开发，于2008年获FDA批准用于治疗冷吡啉相关周期性综合征（CAPS），包括家族性寒冷性自身炎症综合征（FCAS）和Muckle-Wells综合征（MWS）。2020年获FDA批准用于治疗IL-1受体拮抗剂缺乏症（DIRA）。此外，2021年3月，该药物用于复发性心包炎药物（RP）的新适应症再次获FDA批准。根据Kiniksa披露的数据，2023年，ARCALYST®产品净收入为2.332亿美元，同比增长90%。感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下

蛋白降解靶向嵌合体临床3期抗体药物偶联物引进/卖出并购

2024-09-24

·GlobeNewswire-Health Care

Basilea initiates clinical phase 3 study with antifungal fosmanogepix in candidemia and invasive candidiasis

Allschwil, Switzerland, September 24, 2024 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 that it has initiated the Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis (FAST-IC) phase 3 study. This registrational study evaluates the efficacy and safety of Basilea’s broad-spectrum antifungal fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis, that is Candida yeast bloodstream or deep-seated tissue infections.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 Candidemia, including Candida auris, and invasive mold infections.2, 3, 4, 5 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 into FAST-IC. Invasive Candida infections are life-threatening complications for many hospitalized patients and associated with high mortality, and fosmanogepix offers a potential new treatment option in this high medical need area. In addition, we are working towards starting the second phase 3 study investigating fosmanogepix in the treatment of adult patients with invasive mold infections around year-end.” FAST-IC is a global, multi-center, randomized, active-controlled, double-blind phase 3 study and investigates intravenous (i.v.) fosmanogepix versus a standard-of-care regimen of i.v. caspofungin in adult patients with candidemia and/or invasive candidiasis. The study is expected to enroll approximately 450 patients, who will be randomized in a 2:1 ratio to either fosmanogepix or caspofungin. There is an optional oral switch to fosmanogepix in the fosmanogepix group and to fluconazole in the caspofungin group. The Swiss-based global company PSI CRO AG will manage the phase 3 program. Basilea acquired fosmanogepix from Amplyx Pharmaceuticals, Inc., an affiliate of Pfizer Inc., in November 2023. Under the terms of the asset purchase agreement, Basilea assumed all rights and obligations from previous agreements, and will make a USD 6.0 million milestone payment under these obligations, upon the enrolment of the first patient, which is fully reflected in Basilea’s most recent financial guidance for the full year 2024. 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. 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., Scedosporium spp., and some fungi from the Mucorales order.2 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris, and invasive mold infections.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). About invasive mold infections Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., 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.6, 7 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.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 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 press release can be downloaded from www.basilea.com. References ClinicalTrials.gov identifier: NCT05421858K. 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), 2471-2480J. 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: September 23, 2024)B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456 Attachment Press release (PDF).pdf

临床2期临床3期孤儿药快速通道临床结果

100 项与 Fosmanogepix 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11694	-	-	DB15183

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
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
侵袭性曲霉菌病	临床2期	美国	Basilea Pharmaceutica AG	2020-01-04
侵袭性曲霉菌病	临床2期	比利时	Basilea Pharmaceutica AG	2020-01-04
侵袭性曲霉菌病	临床2期	德国	Basilea Pharmaceutica AG	2020-01-04
侵袭性曲霉菌病	临床2期	以色列	Basilea Pharmaceutica AG	2020-01-04
侵袭性真菌感染	临床2期	比利时	Basilea Pharmaceutica AG	2020-01-04
侵袭性真菌感染	临床2期	德国	Basilea Pharmaceutica AG	2020-01-04
侵袭性真菌感染	临床2期	以色列	Basilea Pharmaceutica AG	2020-01-04
耳念珠菌感染	临床2期	南非	Basilea Pharmaceutica AG	2019-12-13

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04804059 (Pubmed) 人工标引	临床1期	-	10	Fosmanogepix 500 mg oral	鏇蓋膚齋觸製顧襯鏇糧(繭鏇簾艱遞醖範襯簾鹽) = 窪鹽觸窪構壓衊積簾構鏇鹽壓膚淵蓋觸鑰範觸 (鹽鹹齋遞獵鏇窪繭鬱觸 )	积极	2024-07-16
NCT04804059 (Pubmed) 人工标引	临床1期	-	10	Fosmanogepix 600 mg IV	鏇蓋膚齋觸製顧襯鏇糧(繭鏇簾艱遞醖範襯簾鹽) = 鹽網範壓醖簾淵網夢糧鏇鹽壓膚淵蓋觸鑰範觸 (鹽鹹齋遞獵鏇窪繭鬱觸 )	积极	2024-07-16
NCT04148287 (Pubmed) 人工标引	临床2期	念珠菌血症	9	Fosmanogepix	衊簾膚窪遞選糧衊憲夢(製憲願餘廠淵選網願構) = 構範壓鏇膚鹽淵窪艱觸膚選壓繭獵蓋齋鹹壓獵 (網衊壓鬱範製壓艱範顧 ) 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	製繭簾顧鑰簾糧鬱鏇鹹(製願遞餘糧鑰簾觸願壓) = 鏇構願膚廠衊獵鬱艱襯製鑰膚顧夢壓簾觸夢蓋 (製齋鑰鏇衊衊製繭簾願 ) 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)	醖艱繭壓憲觸鬱範獵簾(觸蓋鬱憲選夢鑰壓鏇鏇) = 艱齋簾淵糧鏇鏇糧觸鹹衊糧壓製範遞網廠觸製 (積衊餘積鬱鬱鑰選鏇齋, 淵鹹製蓋餘製齋觸夢製 ~ 構夢鏇範簾積願醖憲簾) 更多	-	2023-01-09
NCT03604705 (PipelineReview) 人工标引	临床2期	念珠菌血症一线	21	Fosmanogepix	鏇廠醖鬱鬱範蓋壓憲膚(積鑰網獵鹽襯網衊網廠) = 夢鹽獵夢網鏇簾願網鑰廠構遞膚獵觸餘選願衊 (網範獵顧衊糧範鹹窪窪 ) 更多	积极	2020-07-20