A Phase 2 Trial to Evaluate the EBA, Safety and Tolerability of Ethionamide Alone and in Combination With BVL-GSK098 Administered Orally to Adults With Newly Diagnosed, Rifampicin- and Isoniazid-Susceptible Pulmonary Tuberculosis

To evaluate the 7-day early bactericidal activity (EBA), pharmacokinetics (PK), safety and tolerability of ethionamide (Eto) with or without BVL-GSK098 in participants with rifampicin- and isoniazid-susceptible pulmonary TB.

开始日期2022-12-06

申办/合作机构

TASK Applied Science

NCT04654143 / Completed临床1期

A Phase I, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics and Food Effect of BVL-GSK098 Administered as Single and Multiple Oral Doses to Healthy Volunteers

This is a phase I single-center, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics and food effect of BVL-GSK098 administered as single and multiple oral doses to healthy volunteers

开始日期2020-12-02

申办/合作机构

BioVersys AG

100 项与 Alpibectir 相关的临床结果

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100 项与 Alpibectir 相关的转化医学

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100 项与 Alpibectir 相关的专利（医药）

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项与 Alpibectir 相关的文献（医药）

2024-08-01·DRUG METABOLISM AND DISPOSITION

Alpibectir: Early Qualitative and Quantitative Metabolic Profiling from a First-Time-in-Human Study by Combining¹⁹F-NMR (Nuclear Magnetic Resonance),¹H-NMR, and High-Resolution Mass Spectrometric Analyses

Article

作者: Pieren, Michel ; Boyle, Gary W ; Weston, Daniel J ; Thomas, Steve

Alpibectir (also known as BVL-GSK098 and GSK3729098) is a new chemical entity (NCE) with a novel mechanism for the treatment of tuberculosis. The disposition of alpibectir was determined in subjects from a first-time-in-human trial after a single oral dose of 40 mg and after 7 days repeat dosing at 30 mg. Here we present a combined approach of ¹⁹F-NMR (nuclear magnetic resonance), ¹H-NMR, and high-resolution mass spectrometry (HRMS) to confidently determine the human metabolic fate of alpibectir. Utilizing multiple sites of fluorination in the molecule, it was possible to fractionate human urine and plasma to confidently detect and quantify the metabolite responses using ¹⁹F-NMR. Qualitative detection and structural characterization of F-containing NMR fractions were performed using complementary high-resolution ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS) analyses to further add confidence to the metabolite responses in these fractions. Subsequent ¹H-NMR then provided unequivocal standard-free structural confirmation for key metabolites, which would not be possible with conventional radioactivity detection and LC-MS/MS techniques. Alpibectir was shown to undergo extensive hydrolysis of the central amide moiety, where the resultant N-dealkylated amine and trifluorobutyric acid products were detected initially by unbiased ¹⁹F-NMR detection along with major downstream biotransformations to form a carbamoyl glucuronide conjugate and trifluoroacetic acid, respectively. Parallel UHPLC-MS/MS analyses provided confirmatory or additional structural characterization only where relevant. These concerted data allowed for the qualitative metabolic profile and quantitative determination of drug-related material (DRM) in urine and plasma, along with the percentage of dose excreted in urine, to be reported in a comprehensive, efficient, and data-led manner. SIGNIFICANCE STATEMENT: Combining the selectivity of ¹⁹F-NMR (nuclear magnetic resonance) for unfractionated samples as first-intent, data-led sample fractionation prior to ¹⁹F-NMR and structure-rich ¹H-NMR detection, along with the sensitivity of high-resolution ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS), a novel alternative for time-efficient detection and quantification of drug-related material (DRM) in human without use of radiolabeled drug is reported. This allowed more complete data rationalization of human metabolism, permitting early risk assessment and progression of the development of antitubercular agent, alpibectir.

2024-06-03·The Journal of antimicrobial chemotherapy

First-in-human study of alpibectir (BVL-GSK098), a novel potent anti-TB drug

Article

作者: Davy, Maria ; Martínez-Martínez, María S ; Pefani, Eleni ; Husband, Lisa ; Vlasakakis, Georgios ; Dale, Glenn E ; Antonijoan Arbós, Rosa María ; Penman, Sophie L ; Davila, Myriam ; Abáigar Gutiérrez-Solana, Ana ; Boyle, Gary W ; Zeitlinger, Markus ; Gitzinger, Marc ; Remuiñán, Modesto J ; Pieren, Michel ; Mazarro, Dolores Ochoa

Abstract:

Background:

The clinical candidate alpibectir augments the activity of, and overcomes resistance to, the anti-TB drug ethionamide in vitro and in vivo.

Objectives:

A Phase 1, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK) and food effect of alpibectir administered as single and multiple oral doses in healthy volunteers (NCT04654143).

Methods:

Eighty participants were randomized. In single ascending dose (SAD), a total of six dose levels of alpibectir (0.5 to 40 mg) were tested under fasted and fed (10 mg) conditions as single daily doses in sequential cohorts. In multiple ascending dose (MAD), repeat doses (5 to 30 mg) were administered once daily for 7 days in three sequential cohorts.

Results:

No serious adverse event was reported. Thirteen participants across groups experienced a total of 13 mild or moderate treatment-emergent adverse events. Alpibectir showed rapid absorption after single dose (mean Tmax range of 0.88 to 1.53 h). Food affected the PK of alpibectir, characterized by a slower absorption (mean Tmax 3.87 h), a lower Cmax (−17.7%) and increased AUC0–t (+19.6%) compared with the fasted condition. Following repeat dosing, dose proportionality was shown for both Cmax and AUC0–tau. Accumulation of alpibectir was observed across all doses, with a more profound effect on AUC during a dosing interval (AUC0–tau) compared with Cmax (1.8- and 1.3-fold on average), respectively. Steady state was considered to have been achieved by Day 7 of dosing.

Conclusions:

Alpibectir was generally well tolerated, and no clinically relevant safety findings were identified in the participants treated during SAD or MAD. The PK is dose-proportional and affected by food.

2018-11-01·European journal of medicinal chemistry1区 · 医学

Efficient analoging around ethionamide to explore thioamides bioactivation pathways triggered by boosters in Mycobacterium tuberculosis

1区 · 医学

Article

作者: Baulard, Alain R ; Sournia-Saquet, Alix ; Frita, Rosangela ; Probst, Nicolas ; Prieri, Marion ; Déprez, Benoit ; Willand, Nicolas ; Bourotte, Marilyne

Ethionamide is a key antibiotic prodrug of the second-line chemotherapy regimen to treat tuberculosis. It targets the biosynthesis of mycolic acids thanks to a mycobacterial bioactivation carried out by the Baeyer-Villiger monooxygenase EthA, under the control of a transcriptional repressor called EthR. Recently, the drug-like molecule SMARt-420, which triggers a new transcriptional regulator called EthR2, allowed the derepression a cryptic alternative bioactivation pathway of ethionamide. In order to study the bioactivation of a collection of thioisonicotinamides through the two bioactivation pathways, we developed a new two-step chemical pathway that led to the efficient synthesis of eighteen ethionamide analogues. Measurements of the antimycobacterial activity of these derivatives, used alone and in combination with boosters BDM41906 or SMARt-420, suggest that the two different bioactivation pathways proceed via the same mechanism, which implies the formation of similar metabolites. In addition, an electrochemical study of the aliphatic thioisonicotinamide analogues was undertaken to see whether their oxidation potential correlates with their antitubercular activity measured in the presence or in the absence of the two boosters.

项与 Alpibectir 相关的新闻（医药）

2024-09-24

·GlobeNewswire-Health Care

Nature Reviews Highlights Significant Successes of Antibiotic Collaboration and Calls for Sustainable R&D Funding Schemes

BASEL, Switzerland, Sept. 24, 2024 (GLOBE NEWSWIRE) -- BioVersys AG, a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria, in collaboration with its partners in the AMR Accelerator programme, call for sustainable investment in antimicrobial research and development. Antibiotic resistance is a threat to modern healthcare. Nine European research projects have published in Nature Reviews Drug Discovery an article emphasizing the need to maintain expertise and capability for developing new treatments for infectious diseases, such as those exemplified in the successful European Union’s IMI2 funded TRIC-TB programme. TRIC-TB, successfully reached key milestones, delivering a Phase 2-ready tuberculosis clinical candidate, alpibectir, that is being jointly developed by BioVersys and GSK. The funding that BioVersys as the product developer received, enabled the translation of this exciting new TB therapy into Phase 2a in patients in South Africa. This program now seeks funding to address deadly TB meningitis infections, which predominantly and severely affect children. Together, the nine projects of the AMR Accelerator call on government leaders, the private sector and other stakeholders to invest in the development of new antibiotics and research on antimicrobial resistance (AMR), to secure a sustainable future for large-scale efforts. Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys: “The continued innovation for developing new antibiotics fighting AMR is crucial for modern medicine, in high- and low-income countries. There is simply no way around appropriate funding and market incentives for new antibiotics. Efforts led by the European Union, such as the IMI2 programme should continue and be expanded. However, even more important is to act on adequate reimbursement mechanisms for antibiotics, which are life-saving medicines. We hope that successful projects like TRIC-TB demonstrate the success that adequate funding can deliver.” Dr. David Barros-Aguirre, VP and Head of Global Health Medicines R&D Unit, Global Health R&D, GSK: “Now more than ever, there is a need for sustainable funding mechanisms to combat antimicrobial resistance (AMR), which disproportionately impacts people living in lower income countries. We have witnessed the positive impact of pooled procurement mechanisms in supporting equitable access to new vaccines, building resilience into supply chains and contributing to the development of healthy markets. Yet, these mechanisms do not currently exist for many AMR innovative treatment opportunities.” Antimicrobial resistance is recognised as one of the greatest global challenges of our time, undermining healthcare systems that rely heavily on antibiotics to prevent and treat infections. The need for new antibiotics is well-recognized, and on 26 September, the United Nations General Assembly will spotlight this issue in a high-level meeting on AMR. However, the low return on investment in this area has caused many large pharmaceutical companies to leave the field. This has led to a decline in the rate of development of new drugs and therapies for bacterial infections. The broad scope sets the AMR Accelerator apart from other large-scale efforts: the projects have received funding from the European Commission via the Innovative Medicines Initiative (IMI) and pharmaceutical companies that are members of EFPIA. With a total budget of €479 million, the AMR Accelerator has progressed 44 antibacterial programmes over the past 5 years. So far, the effort has resulted in 16 preclinical and clinical candidates, two completed Phase 1 studies, and five ongoing Phase 1 and 2 studies. The continuing success of the AMR Accelerator demonstrates the value of public-private partnerships, replenishing the antibiotics pipeline and providing tools and infrastructure for the global research community. “In TRIC-TB, we combined an agile, fast-moving SME (BioVersys) with the experience and capabilities of a big industry partner (GSK), to develop an anti-TB drug with an entirely new concept. The small consortium size allowed us to move with speed and agility. In 3½ years TRIC-TB completed CTA-enabling and Phase 1 studies allowing the start of a Phase 2a trial despite the impact of the COVID-19 pandemic”, says Michel Pieren, the TRIC-TB project coordinator, from BioVersys. The AMR Accelerator has created critical mass and synergies that have allowed the transfer of assets, knowledge, and expertise between projects. The results are tangible: better and more efficient science, a strengthening of the antibiotic pipeline, and a legacy of research infrastructures that can support the global fight against antibiotic resistance: these include, standardized infection models, non-clinical assays, clinical trial protocols and regulatory compliant processes. However, the key challenge for all nine projects is to ensure the long-term sustainability of assets, infrastructures and expertise. Which in turn requires a commitment from governments and the pharmaceutical industry to long-term investment in antimicrobial research and antibiotics development. Read the article: https://www-nature-com.libproxy1.nus.edu.sg/articles/d41573-024-00138-9 and DOI: 10.1038/d41573-024-00138-9 About the AMR AcceleratorAMR Accelerator programme was launched in 2019, with the aim to accelerate the development of medicines for patients suffering from infections with drug-resistant Mycobacterium tuberculosis, Nontuberculous mycobacteria (NTM), and Gram-negative bacteria, and build capability for antibiotics research and development. The programme is funded by the Innovative Medicines Initiative (IMI). The AMR Accelerator programme includes nine projects: AB-Direct, COMBINE, ERA4TB, GNA NOW, PriMAVeRa, RespiriNTM & RespiriTB, TRIC-TB, and UNITE4TB. Together, the projects have a €479 million budget. The 98 partners represent key stakeholders from academia, industry, small- and medium-sized companies, patient organisations, regulators, and Health Technology Assessment. IMI projects are public-private partnerships, funded in equal parts by the European Union’s Horizon 2020-programme and the pharmaceutical companies that are members of EFPIA. More information: www.amr-accelerator.eu AMR Accelerator portfolio: https://amr-accelerator.eu/amr-accelerator-project-portfolio/ The AMR Accelerator has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under Grant Agreements No 853967 I 853989 I 853979 I 853932 I 853800 I 853903 I 853976 I 101007873 I 101034420. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. ERA4TB receives additional support from Global Alliance for TB Drug Development, Bill & Melinda Gates Foundation and University of Dundee. UNITE4TB receives additional support from Deutsches Zentrum für Infektionsforschung e. V. (DZIF), and Ludwig-Maximilians-Universität München (LMU). EFPIA/AP contribute to 50% of funding, whereas the contribution of DZIF and the LMU University Hospital Munich has been granted by the German Federal Ministry of Education and Research. Disclaimer: This text reflects the author’s view. Neither IMI nor the European Union, EFPIA or any other third parties are responsible for any use that may be made of the information contained herein. The COMBINE project has a coordinating role in the AMR Accelerator programme. For more information, please contact Anders Karlén, Professor of Computer-Aided Drug Design, Uppsala University & project coordinator, COMBINE. E-mail: anders.karlen@uu.se or Marie Olliver, Alliance manager COMBINE, Uppsala University. E-mail: marie.olliver@uu.se. About TRIC-TBTRIC-TB successfully completed the Phase 1 study with alpibectir (BVL-GSK098), a small molecule potentiating the activity of ethionamide. It is hoped alpibectir would allow lower doses of ethionamide thus minimizing dose-dependent side effects and, it is hoped, improving patient compliance. In laboratory tests, the combination of alpibectir/ethionamide (AlpE) is rapidly bactericidal, overcomes MDR and Eto-resistance, and shows the potential to become an important building block in novel regimens in TB endemic countries. AlpE is currently tested in a Phase 2a proof-of-concept study (NCT05473195). TRIC-TB has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under Grant Agreement No 853800. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA companies’ in-kind contribution. For more information, please contact Michel Pieren, Clinical Program Team Leader, BioVersys & TRIC-TB project coordinator. E-mail: michel.pieren@bioversys.com About GSKGSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com About BioVersysBioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 2), and tuberculosis (alpibectir, Phase 2a, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland. BioVersys contact Sylvia Mundt, Executive Assistant to CEO, Tel. +41 61 633 22 50 ; Mail : IR@bioversys.com Website: www.bioversys.com https://twitter.com/Bioversyshttps://www.linkedin.com/company/bioversys-ag

临床2期临床1期

2024-09-12

·动脉网

【首发】广州中以二期基金加码瑞士制药公司BioVersys AG，落户广州国际生物岛并加速研发AMR及抗肺结核药物

本轮资金近日，广州中以二期生物产业投资基金（以下简称“中以基金”）宣布，参与瑞士BioVersys AG公司的C+轮融资，投资总额约为4200万元人民币，此举标志着中以基金首次进入全球抗生素耐药（AMR）领域。同时BioVersys AG宣布，将其中国总部落户于广州国际生物岛，以加强与中国市场的紧密联系，推动公司产品的临床进度，聚焦中国AMR以及抗肺结核领域的治疗。中以基金对BioVersys AG的本轮投资资金，将主要用于创新药管线BV100的临床开发和中国总部的团队建设，打造针对多种适应症的新型抗生素产品矩阵。BV100是用于解决致命的碳青霉烯类耐药鲍曼不动杆菌（CRAB）感染的创新疗法。 2023年1月，全球最大的专注于抗微生物耐药治疗领域的公共性私募投资基金AMR Action Fund对BioVersys AG 进行了投资，也是该基金第一笔在欧洲的投资。自BioVersys AG成立以来，已成功筹集约1.3亿瑞士法郎的股权投资以及政策扶持资金。凭借卓越的研发实力和创新药物管线，BioVersys AG也赢得了国际顶尖跨国药企葛兰素史克的认可，基于这一认可，两家公司携手合作，共同推进肺结核治疗药物Alpibectir的研发工作。在中国市场，对于新型、高效且具有低耐药性的抗菌药物的需求日益增长。BioVersys AG的BV100和Alpibectir药物管线，凭借创新性和潜在的治疗效果，在中国这一充满活力的增长型市场中展现出巨大的市场潜力。此次中以基金将对BioVersys AG的投资引进广州，是在广州市及黄埔区政府支持下，生物医药产业发展的又一重要成果，标志着广州在引进国际优质项目、推动本地生物医药产业发展方面迈出了坚实的步伐。中以基金的这一举措不仅为BioVersys AG提供了进入中国市场的桥梁，也为广州带来了先进的生物医药技术和管理经验，有助于提升广州在全球生物医药领域的竞争力。通过此类投资，中以基金正不断加强广州的生物医药生态系统建设，促进产业链上下游的协同发展，为广州市打造国际化的生物医药创新高地提供强有力的支撑。同时，这也将进一步吸引更多的国内外优秀企业和人才汇聚广州，共同推动广州生物医药产业的繁荣发展。关于广州中以二期生物产业投资基金广州中以生物产业投资基金（中以基金）于2016年在广州国际生物岛设立，由广州市政府财政资金和国企共同出资。中以基金是国内首支由以色列团队主导管理，专注于医疗领域的人民币投资基金。第一期基金规模为人民币6.06亿元，已投资12个领先的医疗器械和数字健康以色列公司。2021年底，尽管面临严峻的疫情，中以基金管理团队获得广州高新区投资集团和广州国际生物岛集团的大力支持，完成了设定规模人民币18亿元的中以二期基金的首次募资（人民币6亿元）。中以二期基金聚焦投资处于临床试验阶段的国际创新药公司。关于BioVersys AG BioVersys AG 位于瑞士巴塞尔，是一家多管线临床试验阶段的生物制药公司。公司专注于识别、开发和商业化新型抗菌产品，以治疗由多重耐药（"MDR"）细菌引起的严重、危及生命的感染。该公司的候选产品源自其两个内部技术平台（TRIC 和 Ansamycin Chemistry），旨在克服耐药机制、阻断毒力产生，并直接影响有害细菌的致病性，以识别抗菌和微生物组领域的新治疗选择。这使得 BioVersys 能够解决对新疗法的高未满足医疗需求，以对抗危及生命的耐药细菌感染和细菌加剧的慢性炎症性微生物组疾病。公司最先进的研发项目针对的是医院感染的鲍曼不动杆菌（BV100）以及结核病（alpibectir）均处于临床试验2期阶段。 *封面图片来源：123rf 如果您想对接文章中提到的项目，或您的项目想被动脉网报道，或者发布融资新闻，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

微生物疗法临床2期

2024-09-11

·GlobeNewswire-Health Care

Bioversys Announces Strategic Investment From GIBF2 and Launch of BV100 Clinical Program in China

BASEL, Switzerland, Sept. 11, 2024 (GLOBE NEWSWIRE) -- GIBF2 to invest US$ 6m in BioVersys BV100 Phase 1 study in China expected to start in 1H 2025 in preparation for a global Phase 3 registrational study BioVersys AG, a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant ("MDR") bacteria, announced today the strategic investment by investment firm Guangzhou Sino-Israel Bio-Industry Investment Fund 2 LLP (GIBF) of US$ 6m (approximately CHF 5.17m). The investment aligns with BioVersys’ strategic decision to expand the clinical development of its lead asset BV100 in China, to address a large unmet medical need affecting a very large patient population and offering a significant market opportunity. Infections by Carbapenem-Resistant Acinetobacter baumannii (CRAB) have become a major issue in China, with an increase in the resistance rate from 32-41% in 2005 to over 75% in 2018, associated with high mortality rates in ICUs. GIBF’s support for clinical trials and its extensive network in China are expected to facilitate and accelerate the clinical development of BV100. Onboarding China to BioVersys’ planned global Phase 3 clinical trial first requires a small Phase 1 study in healthy volunteers to confirm the safety and pharmacokinetic profile of BV100 in the Chinese population. This Phase 1 is on track to be initiated by early 2025 and will be followed by the onboarding of Chinese patients into the planned global Phase 3 registrational study. Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys: "We are very pleased to announce this new strategic partnership with the highly regarded investment firm GIBF, which will serve to further expedite the clinical development of our lead asset BV100 in China. We have long recognized the huge potential of the market there, and with BV100 having already demonstrated significant potential to become an essential anti-infective treatment, we look forward to getting our clinical evaluation in China underway and to bringing BV100 to patients in need as soon as possible both in China and other markets." Dr. Shuki Gleitman, Founding Partner and Chairman of the Guangzhou-Israel Biotechnology Fund: "GIBF’s core focus on healthcare has allowed the firm to raise US$ 400 million since its creation in 2016 and to invest in projects which we believe will make a significant impact on the Chinese healthcare system. Resistance to antibiotics has become a leading cause of death and BV100 has started generating impressive clinical data, which we believe will make it a key asset in the treatment armamentarium of hospitals in China and around the world. We look forward to supporting BioVersys in its efforts to develop innovative anti-infective treatments in China." About the Guangzhou-Israel Biotechnology FundWith years of life sciences expertise, private equity investment experience, local knowledge based on over a decade of activity in China, and numerous foreign companies already established in China, GIBF serves as an invaluable strategic investor and partner in China with a proven ability and track record of supporting multi-center clinical trials in top-tier Chinese hospitals, providing the resources and networks for securing successful NMPA submissions, commercializing products and developing manufacturing capacity to satisfy both local and global demand. For further information please visit https://gibf-bio.com/en About BioVersysBioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 2), and tuberculosis (alpibectir, Phase 2a, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland. BioVersys contact Sylvia Mundt, Executive Assistant to CEO, Tel. +41 61 633 22 50; Mail: IR@bioversys.com www.bioversys.comX: www.twitter.com/BioversysLinkedin: www.linkedin.com/company/bioversys-ag

临床2期临床3期微生物疗法

100 项与 Alpibectir 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
肺结核	临床2期	南非	TASK Applied Science	2022-12-06
结核	临床2期	南非	BioVersys AG	-

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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


NCT04654143 (Pubmed) 人工标引	临床1期	-	80	Alpibectir(0.5 to 40 mg) (single ascending dose (SAD))	膚網遞範壓鬱壓糧膚觸(網願廠壓鹽膚衊範範鏇) = No serious adverse event was reported. Thirteen participants across groups experienced a total of 13 mild or moderate treatment-emergent adverse events 鬱憲顧鏇蓋繭遞積鏇製 (膚蓋積觸壓鏇簾膚鏇鏇 ) 更多	积极	2024-04-24
				Alpibectir(5 to 30 mg) (multiple ascending dose (MAD))