A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Operationally Seamless Phase 2/3 Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of AIC263029 in the Treatment of BKV Infection in Kidney Transplant Recipients

The goal of this clinical trial is to learn if AIC263029 is safe and well tolerated in adult kidney transplant recipients with BK virus (BKV) in the blood (viremia). The study will also examine how the body processes AIC263029 and whether it lowers BKV levels in the blood.
Researchers will compare AIC263029 to a placebo (a look-alike injection with no active drug). Participants will be assigned by chance to receive AIC263029 or placebo and will receive weekly injections under the skin for 4 weeks. Participants will have clinic visits and blood tests during treatment and follow-up to monitor safety and measure BKV levels, and will be followed for up to about 24 weeks after treatment.

开始日期2026-06-15

申办/合作机构

Aicuris Anti-Infective Cures AG

CTIS2023-510074-13-00

/ Completed临床1期

A clinical trial to determine if AIC263029 is safe when dosed only once or several times, and to investigate how it moves within the human body

开始日期2024-10-02

申办/合作机构

Aicuris Anti-Infective Cures AG

NCT05671029

/ Completed临床1期

A Double-blind, Single-center, Randomized, Placebo- and Positive-controlled, Parallel-group Trial With a Nested Crossover Part on the Electrocardiographic Effects 100 and 400 mg Pritelivir Per Day in Healthy Subjects: a Thorough QT/QTc Trial

This Phase 1 clinical trial was a double-blind, single-center, randomized and placebo-controlled trial in which healthy male and female subjects received in 2 parallel-groups daily oral doses of pritelivir (Group 1) or matching placebo (Group 2). Within Group 2, a single oral administration of moxifloxacin (positive control) and corresponding matching placebo was administered in a 2-sequence crossover design (nested crossover).

开始日期2022-12-04

申办/合作机构

Aicuris Anti-Infective Cures AG

100 项与 Aicuris Anti-Infective Cures AG 相关的临床结果

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0 项与 Aicuris Anti-Infective Cures AG 相关的专利（医药）

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项与 Aicuris Anti-Infective Cures AG 相关的文献（医药）

2025-07-01·ANTIVIRAL RESEARCH

The conserved core nuclear egress complex (NEC) as an antiherpesviral drug target: Pharmacophore-based identification of NEC-specific inhibitors

Article

作者: Buschmann, Helmut ; Sticht, Heinrich ; Wagner, Sabrina ; Hahn, Friedrich ; Langer, Thierry ; Geiger, Pia ; Marschall, Manfred ; Lesch, Bernhard ; Lischka, Peter ; Obergfäll, Debora ; Tillmanns, Julia ; Battisti, Verena ; Kicuntod, Jintawee

The nucleocytoplasmic capsid egress of herpesviruses is a uniquely regulated process. As well-established for the human cytomegalovirus (HCMV) core nuclear egress complex (NEC), the pUL50-pUL53 NEC heterodimer oligomerizes and builds hexameric lattices for the regulated nucleocytoplasmic release of viral capsids. Recently, we and others validated the NEC as a novel target for antiviral strategies. So far, the experimental targeting approaches included the development of NEC-directed small molecules, cell-penetrating peptides, NEC-specific mutagenesis, and the expression of NEC-interfering protein constructs. Our current postulate states that a small molecule-mediated interference with the assembly of the core NEC prevents NEC-dependent egress regulation and thereby strictly limits viral replication. Here, we present an experimental proof of this antiviral strategy, and the data provide evidence for the following points: (i) pharmacophore-based approaches demonstrated to be successful in the identification of NEC-specific inhibitory small molecules, (ii) already a low number of 36 analyzed small molecules yielded eight experimental hits with micromolar to submicromolar antiviral activity, (iii) their antiviral potency was asserted to the predicted NEC-interfering mode-of-action, (iv) two identified hit compounds presented a broad antiherpesviral activity, and (v) a further pharmacophore-assisted refinement of NEC-directed molecules may lead to the development of highly effective and even broadly acting antivirals. Combined, we strengthen the recently postulated potential of the NEC as a next-generation antiherpesviral drug target by identifying broadly active NEC inhibitors via a pharmacophore-based approach.

2025-05-01·ANTIVIRAL RESEARCH

Overview on the management of herpes simplex virus infections: Current therapies and future directions

Review

作者: Birkmann, Alexander ; Saunders, Rob

INTRODUCTION:

Herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) are highly prevalent, infecting approximately 64 % and 13 % of the world's population, respectively. Traditionally, HSV-1 has been associated with orofacial infections and HSV-2 with anogenital infections, but HSV-1 is increasingly the cause of genital infections. The clinical spectrum of HSV disease ranges from mild cold sores to severe conditions such as encephalitis or systemic infection, particularly in immunocompromised individuals and neonates.

AREAS COVERED:

Here we summarize the natural history, epidemiology, manifestations, and treatment options for HSV infections. Current treatments, such as acyclovir, target viral DNA polymerase but have limited efficacy and are susceptible to resistance, especially in immunosuppressed populations. Rescue therapies such as foscarnet exhibit limiting toxicity. Vaccine development has been challenging, and a cure for HSV infection remains distant. Gene therapy is still in its early stages, while novel drugs such as helicase primase inhibitors (HPIs) are emerging as a promising alternative, showing high efficacy and the potential to overcome resistance.

EXPERT OPINION:

HPIs represent a significant advance in HSV management. Their safety profile and novel mode of action may provide better viral suppression with a lower risk of resistance, offering hope for better control of the disease.

2025-03-27·JOURNAL OF MEDICINAL CHEMISTRY

Discovery of AIC263282, a Hepatitis B Virus Capsid Assembly Modulator Ready for Candidate Profiling

Article

作者: Slootweg, Jack C. ; Lesch, Bernhard ; Birkmann, Alexander ; Bonsmann, Susanne ; Wegert, Anita ; Sarmentero, Maria Ángeles ; Cuevas, Félix ; Sinnige, Wessel ; Detta, Elena ; García, Jordi González ; Pfaff, Tamara ; Cnossen, Arjen ; Goldner, Thomas ; Zimmermann, Holger ; Bosnidou, Alexandra E. ; Font, Daniel ; Donald, Alastair ; Buschmann, Helmut ; Engel, Florian ; del Castillo, Estefanía ; Kumar, Kamal ; Raymond, Justine ; Urban, Andreas

Hepatitis B Virus (HBV) infections remain a threat to the global public health. Nucleoside analogues remain the mainstay of therapy despite their discouraging cure rates achieved. Capsid assembly modulators (CAMs) have been at the center of HBV research, but despite having shown clinical efficacy on viral load in clinical studies, market entry has been elusive. Herein, we present the optimization program of our lead series. Setting our focus on potency, solubility, and hERG liability, these studies resulted in AIC263282, a new, potent capsid assembly modulator with improved physicochemical properties, which is ready for profiling as a preclinical candidate.

项与 Aicuris Anti-Infective Cures AG 相关的新闻（医药）

2026-03-06

·NovaTechBluePrint 星科蓝图

2026年3月第一周全球生物制药行业简报

2026年3月第一周,全球生物制药行业延续开年强劲势头。跨国药企加速中国战略投资,并购交易金额屡创新高;FDA推进加速审批通道;中国本土药企迎来新一轮出海高峰。本期简报围绕全球动态、技术发展、趋势预测、国内分析四大板块,梳理关键信息,揭示产业演进内在逻辑。 01.全球生物制药行业动态投资与融资 BioPharma Credit PLC增资2亿美元: 3月2日,BioPharma Credit PLC宣布与UroGen Pharma Ltd.修订贷款协议,将原有1.25亿美元优先担保贷款增至2亿美元(新增7500万美元),并增设最高5000万美元的B档额度,总贷款额度可达2.5亿美元。公司同时获得一次性150万美元额外对价。早期生物技术融资活跃: Bioworld Asia数据显示,3月4日单日有Antiverse、Beken、Informuta、Maia、Modular、Poplar、Prolium、Xsensio等8家公司完成公开或私募融资,其中Antiverse获930万美元A轮融资,用于扩展AI抗体设计平台。并购交易礼来、吉利德等头部企业频繁出手: 2026年开年以来,全球医药并购潮持续升温。礼来宣布以高达24亿美元收购体内CAR-T公司Orna Therapeutics;吉利德科学拟以78亿美元收购长期合作伙伴Arcellx,核心标的为BCMA导向CAR-T疗法Anito-cel;日本旭化成株式会社以约7.8亿欧元收购德国生物制药公司Aicuris Anti-infective Cures AG。 Candid Therapeutics反向合并上市: 通过与罕见病药企Rallybio的反向合并,Candid Therapeutics成功登陆纳斯达克,并完成5.05亿美元私募融资,资金将用于推进T细胞衔接器管线。监管审批 FDA批准第三项国家优先凭证项目: 3月5日,FDA批准teclistamab联合daratumumab hyaluronidase-fihj(Tec-Dara)用于治疗至少接受过一线治疗的复发/难治性多发性骨髓瘤成人患者。该决定在提交后55天内做出,是新的局长国家优先凭证(CNPV)试点计划下的第三项批准。中国创新药获批进展: 罗伐昔替尼(商品名安煦®)于2月28日获NMPA批准上市,用于中高危骨髓纤维化患者的一线治疗,成为中国移植领域重要突破。生物医药研发实验室场景 02.生物制药技术与设备发展行业展会与技术交流济南国际生物医药与技术装备展览会: 定于3月9日至11日在济南黄河国际会展中心举行,主题为"创新·融合·发展",将集中展示生物医药前沿技术、先进装备与科研成果,覆盖从研发到生产的全流程。北京国际制药设备与包装机械展: 3月4日至6日在北京举办,聚焦制药工艺装备、包装技术及自动化解决方案。设备市场趋势制药设备市场规模持续扩大: 根据GlobeNewswire最新报告,2026-2032年全球制药设备市场预计将达到219.7亿美元,年均复合增长率保持高位。驱动力包括自动化需求、生物药生产扩张、区域投资转移以及可持续发展要求。创新技术应用: 磁悬浮泵(Levitronix)、智能控制系统、实时分析平台等先进设备正逐步成为生物制药生产的标配,助力企业提升产率、降低能耗。研发资金支持多国政府与研究机构发布资助计划:印度DBT(生物技术部)、ICMR(医学研究理事会)、DST(科学技术部)以及英国科学院等机构均在3月设有研究提案截止日期,重点支持生物技术、健康科学等领域的前沿探索。 03.趋势预测医药并购活动将进入新一轮高峰期行业分析机构预测: Biospectrum Asia最新分析指出,在2025年并购交易总额达2400亿美元(同比增长81%)的基础上,2026年医药并购活动预计将进一步繁荣。核心驱动力包括专利悬崖压力、管线补充需求以及中国等新兴市场资产吸引力上升。交易结构变化: 大型交易数量增加,且更多涉及前沿技术领域(如细胞与基因治疗、AI药物发现),显示产业资源正向创新高地集中。中国创新药全球化进程加速海外授权交易规模与频次双升: 2026年前两个月,中国创新药对外授权潜在总金额已超1300亿美元,交易标的从早期临床前项目延伸至临床后期成熟资产。预计全年将有更多类似中国生物制药-赛诺菲的重磅合作落地。国际化能力建设: 本土药企正通过自建海外团队、与CRO/CMO合作、参与国际临床研究等方式,系统性提升全球开发与商业化能力。现代生物医药研发设备 04.中国国内生命科学领域发展与市场动向政策环境持续优化居民医保财政补助标准提高: 2026年政府工作报告明确提出,居民医保人均财政补助标准提高24元,进一步减轻群众就医负担。集采制度深化: 第11批集采已在大部分省市落地执行,第12批集采(预计涵盖168个品种)进入筹划阶段。政策导向从"降价"向"价值医疗"过渡,鼓励创新药研发。生物医药列为新兴支柱产业: 政府工作报告首次将生物医药与集成电路、航空航天等并列,作为培育新质生产力的关键领域,预计将获得更多政策与资金支持。本土企业动态中国生物制药创移植领域最大对外授权: 3月4日,中国生物制药子公司正大天晴与赛诺菲就JAK/ROCK双靶点抑制剂罗伐昔替尼达成独家全球授权协议,交易总额最高达15.3亿美元(含1.35亿美元首付款)。这是中国药企在移植领域规模最大的对外授权,标志着本土创新实力获国际顶级认可。君赛生物TIL疗法获临床受理: 2月27日,君赛生物申报的自体天然肿瘤浸润淋巴细胞注射液获CDE受理,成为2026年国内首个进入临床阶段的TIL疗法,为实体瘤患者带来新希望。亚虹医药宫颈癌前病变无创治疗产品获批: APL-1702(商品名希维她)获NMPA批准上市,成为国内首个宫颈癌前病变无创治疗产品,实现该领域"从0到1"的突破。市场与投资趋势跨国药企加大在华投资: 2026年,赛诺菲、诺和诺德、罗氏、诺华等跨国巨头纷纷宣布在华新增研发中心或扩建生产基地,累计投资额超百亿美元。中国市场正从"生产车间"向"创新策源地"转型。生命科学服务行业高速增长: 2024年中国生命科学服务市场规模约1280亿元,同比增长18.5%,预计2026年将突破2000亿元。生物制药研发服务、基因检测服务、细胞治疗技术服务等细分领域增长尤为显著。生物医药创新突破📊 行业核心特征资本高度活跃: 风险投资、公开市场融资、并购交易资金规模前所未有,突破性技术早期公司受追捧监管协同加速: FDA、NMPA通过优先审评、加速批准推动创新疗法快速惠及患者中国角色升级: 从"市场"到"合作伙伴"再到"创新源头",全球价值链地位持续提升🎯 项目经理机遇与挑战机遇: 参与跨国药企在华新建/扩建项目为中国创新药企海外临床研究提供工程支持关注细胞与基因治疗等新兴领域基础设施需求挑战: 应对技术迭代带来的工艺变更压力适应不同国家/地区的监管与质量标准在全球化合作中管理文化与时区差异参考文献全球行业动态 UPDATE ON INVESTMENT – BioPharma Credit PLC, 2026-03-02. - Financings for March 4, 2026 – Bioworld Asia, 2026-03-04. - FDA Grants Third Approval Under the National Priority Voucher Program – FDA Newsroom, 2026-03-05. 技术设备发展 Proposals to Submit in March 2026: Major Funding Opportunities for Researchers – PhD Talks, 2026-03-03. - Pharmaceutical Manufacturing Equipment Report 2026-2032: $21.97 Bn Market – GlobeNewswire, 2026-03-04. China Beijing International Pharmaceutical Equipment and Packaging Machinery Exhibition 2026 – Canton Fair, 2026-03-01. 趋势预测 Pharma M&A set to boom in 2026 – Biospectrum Asia, 2026-03-01. 国内分析 - 兴业证券-医药行业2026年3月投资月报 – 慧博投研资讯, 2026-03-03. 链接Big Pharma Expands Investments in China: 2026 Overview – Pharmaceutical Tech, 2026-03-04. 链接2026济南国际生物医药与技术装备展览会 – 11467.com, 2026-03-05. 链接中国生物制药与赛诺菲达成15.3亿美元独家授权协议 – 证券时报e公司, 2026-03-04. 链接2026年政府工作报告医疗政策解读 – 经济观察报, 2026-03-05. 链接君赛生物TIL疗法获临床受理 – 光明网, 2026-03-02. 链接2026及未来5年中国生命科学服务行业发展报告 – 原创力文档, 2026-02-28. 链接注: 以上信息基于2026年2月28日至3月5日的公开网络搜索结果,仅供参考。具体数据与进展请以官方发布为准。

细胞疗法免疫疗法上市批准并购

2026-03-04

·制药网

2026 开年医药现并购潮，礼来、吉利德等海外头部频频出手

【制药网行业动态】2026年开年至今，全球医药行业迎来了一波强劲的并购潮。其中，海外头部为应对专利悬崖、锁定前沿技术、巩固全球地位，交易已呈现金额屡创新高、赛道高度集中的特征。　　如3月2日消息，Candid Therapeutics宣布与Rallybio合并，并完成超5.05亿美元私募融资，资金将用于推进其T细胞衔接器管线。　　合并后公司由Candid现任董事长、总裁兼首席执行官Ken Song博士领导。同时，公司将继续推进其多元化TCE管线的关键临床里程碑，包括计划于2026年启动针对重症肌无力及风湿性疾病继发间质性肺病的2期临床研究。　　2月26日,，日本旭化成株式会社宣布，已签署最终协议，以约7.8亿欧元收购德国伍珀塔尔市生物制药公司Aicuris Anti-infective Cures AG的全部已发行股份，交易预计于2026年第二季度完成。　　此次收购旨在强化旭化成在免疫功能低下及复杂病症患者群体的治疗布局。并助力其实现2030财年药品净销售额3000亿日元、营业利润率15%以上的目标。　　2月23日，吉利德科学宣布将以78亿美元的价格收购其长期合作的开发伙伴Arcellx公司。旨在进一步巩固吉利德在肿瘤免疫治疗领域的竞争力，尤其聚焦多发性骨髓瘤治疗赛道的布局深化。　　此次收购的核心标的为Arcellx旗下研究性BCMA导向CAR-T细胞疗法Anito-cel(阿尼托卡布他基因自体淋巴细胞注射液)，该管线是双方2022年合作基础上的重点推进项目，目前已进入商业化冲刺阶段，有望在年内获批上市。　　2月9日，礼来宣布与一家体内CAR-T公司Orna Therapeutics达成最终收购协议。根据协议条款，Orna Therapeutics股东可能获得高达24亿美元现金，包括预付款以及在达到特定临床开发里程碑后的后续付款。　　目前，Orna Therapeutics的管线项目均处于临床前阶段。其中，核心项目ORN-252是一款已具备临床申报条件、靶向CD19的体内CAR-T疗法，主要用于治疗B细胞介导的自身免疫性疾病，这是礼来重点关注的领域。　　除了上述企业，近两个月内，安进、阿斯利康、波士顿科学、葛兰素史克等众多企业也已相继发起过几亿——上百亿美元的交易。其中，IVD 诊断、肿瘤免疫、细胞与基因治疗三大赛道较为集中，单笔交易金额屡破百亿美元。　　业内分析认为，这些密集且大额的收购，核心驱动力是跨国药企面临的专利悬崖压力。未来，通过并购整合优质资产、扩充管线将成为越来越多药企应对挑战的核心战略选择。　　免责声明：在任何情况下，本文中的信息或表述的意见，均不构成对任何人的投资建议。

并购细胞疗法免疫疗法临床2期

2026-03-03

·allsci.com

Asahi Kasei acquires Aicuris for anti-infective cures in EUR 780m deal

Asahi Kasei has agreed to acquire Germany-based Aicuris Anti-infective Cures AG for approximately EUR 780 million (USD 919 million), strengthening the Japanese group’s infectious disease portfolio focused on immunocompromised patients. The transaction will see Asahi Kasei purchase all issued shares of Aicuris and is expected to close by June 2026, subject to customary conditions. The acquisition adds a pipeline of antiviral therapies targeting infections common in transplant recipients and other immunocompromised populations, complementing Asahi Kasei’s existing presence in transplantation and nephrology. Aicuris pipeline and technologies Aicuris brings three key antiviral assets to Asahi Kasei. Prevymis (letermovir), a cytomegalovirus (CMV) terminase inhibitor discovered by Aicuris, is marketed globally by Merck under license. The drug is approved for CMV prophylaxis in transplant patients, and Aicuris receives royalties as the originator. These royalty revenues will transfer to Asahi Kasei after the acquisition closes. Pritelivir is a helicase-primase inhibitor targeting herpes simplex virus (HSV) infections in immunocompromised patients. The mechanism differs from nucleoside analog antivirals such as acyclovir, enabling activity against drug-resistant HSV strains. Pritelivir has received FDA Fast Track and Breakthrough Therapy designations, and Phase III studies have been completed, with a regulatory submission anticipated in 2026. The company’s earlier-stage program, AIC468, is an antisense oligonucleotide designed to inhibit replication of BK virus (BKV) in kidney transplant recipients. The therapy has completed Phase I development. No antiviral therapies are currently approved in the United States for BK virus infection. Strategic expansion in transplant and nephrology The acquisition continues Asahi Kasei’s strategy of building a specialty pharmaceutical platform focused on diseases affecting transplant recipients and kidney patients. The company acquired Veloxis Pharmaceuticals in 2020 for USD 1.3 billion, gaining the transplant immunosuppressant Envarsus XR, and Calliditas Therapeutics in 2024 for approximately USD 1.1 billion, adding Tarpeyo for IgA nephropathy. With Aicuris, Asahi Kasei expands into antiviral treatments for infections that frequently complicate transplantation, including CMV reactivation, HSV disease, and BK virus nephropathy. These infections remain significant clinical risks in transplant recipients despite advances in immunosuppressive therapy. Market and competitive landscape The antiviral pipeline targeting transplant-associated infections has drawn increasing industry interest in recent years. Programs in development include BK virus therapies such as MAU868, a monoclonal antibody currently in clinical trials, and next-generation HSV antivirals being developed by companies including Assembly Biosciences. Against this backdrop, the Aicuris acquisition provides Asahi Kasei with a combination of near-term commercial potential through pritelivir, existing royalty revenue from letermovir, and earlier-stage pipeline assets, strengthening its position in transplant medicine. The company expects the acquisition to contribute to operating income beginning in fiscal 2028, as it builds a broader pharmaceutical portfolio spanning transplantation, nephrology, and infectious diseases.

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药物(靶点)	适应症	全球最高研发状态

普利特利韦 ( DNA helicase/primase complex )	单纯疱疹更多	临床3期
AIC-468	BK病毒感染更多	临床2期
Art-175	对多种药物耐药的传染病更多	临床前
Compound 42(AiCuris Anti-infective Cures) ( HBV capsid )	慢性乙型肝炎更多	临床前
Compound 56(AiCuris Anti-infective Cures) ( HBV capsid )	慢性乙型肝炎更多	临床前