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

NL-OMON50697

/ CompletedN/A

A single-center, open-label, fixed-sequence Phase 1 trial to evaluate the effect of multiple doses of pritelivir on the pharmacokinetics of substrates for CYP2C9, CYP2B6, CYP3A4 and OATP2B1 - Pritelivir DDI study with celiprolol, flurbiprofen, bupropion and midazolam

开始日期2021-10-18

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 ; García, Jordi González ; Detta, Elena ; Pfaff, Tamara ; Goldner, Thomas ; Cnossen, Arjen ; 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）

2026-03-04

·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.

上市批准临床1期并购快速通道突破性疗法

2026-02-27

·蒲公英资讯

9.19亿美元！旭化成收购德国抗感染公司Aicuris

2026年2月26日，旭化成宣布已签署最终协议，以约7.8亿欧元（约合9.19亿美元）收购德国生物制药公司Aicuris Anti-infective Cures AG的全部已发行股份。交易预计在2026财年第一季度完成，旭化成预计从2028财年起，该交易将对营业收入产生正面贡献。专注严重感染性疾病的德国biotech Aicuris是一家2006年从拜耳（Bayer）剥离出来的生物制药公司，专注于开发严重感染性疾病疗法，其核心资产包括三款差异化产品： 1. Prevymis（来特莫韦）：已上市药物，授权给默沙东（Merck & Co.），用于预防移植受者的巨细胞病毒（CMV）感染。该产品2025年为默沙东贡献了9.78亿美元销售额，可为旭化成带来持续的特许权使用费收入。 2. Pritelivir：口服单纯疱疹病毒（HSV）感染治疗药物，已完成III期临床试验，目标在2026年获得FDA批准。该药针对免疫功能低下患者的HSV感染，特别是对阿昔洛韦耐药的患者，拥有全新的作用机制。 3. AIC468：反义寡核苷酸药物，用于治疗肾移植患者的BK病毒感染，已完成I期临床试验，目标2030年实现商业化。BK病毒感染是肾移植后常见的并发症，目前缺乏有效的治疗选择。移植+肾脏+抗感染的闭环布局此次收购与旭化成现有的移植和肾脏病业务高度契合。旭化成通过此前收购的Veloxis（移植领域）和Calliditas（肾脏疾病）子公司，已在移植和肾脏领域建立起稳固的商业基础设施。Aicuris的抗感染管线正好补全了移植患者术后感染管理的拼图——移植受者因免疫抑制状态，极易受到CMV、HSV、BKV等病毒感染。旭化成医疗保健板块负责人表示：“此次收购加强了我们在相互关联的治疗领域的地位，包括自身免疫性疾病、移植、肾脏疾病和严重感染性疾病。它增强了我们的管线，并强化了我们打造领先全球专业制药公司的战略。” 2030年制药业务净销售额3000亿日元旭化成已将制药业务定位为当前中期管理计划下的优先业务。公司目标到2030财年实现制药业务净销售额3000亿日元（约合19.26亿美元），营业利润率15%或以上。此次收购为旭化成带来了分层式的增长结构：即期收入：Prevymis带来的持续特许权使用费收入近期驱动：Pritelivir若2026年获批，有望在2030年代中期实现峰值销售额超4亿美元长期潜力：AIC468为2030年后的增长埋下伏笔旭化成的医药扩张路径这是旭化成近年来在医药领域的又一次大规模并购： 2020年：约1400亿日元（约合8.99亿美元）收购美国生物技术公司Veloxis 2024年：约1700亿日元（约合10.91亿美元）收购瑞典制药公司Calliditas 2026年：约1431亿日元（约合9.19亿美元）收购德国Aicuris 旭化成的策略路线清晰，聚焦竞争相对较小、小规模体制也易于切入的利基领域，通过并购构建差异化管线。就在此次收购宣布的前一天（2月25日），旭化成还与日本AI药物发现公司Alchemedicine签署了针对自身免疫疾病的全球独家许可协议。 M&A市场持续升温 Aicuris收购案是近期生物技术并购潮的又一例证。就在本周，GSK以9.5亿美元收购加拿大biotech 35Pharma，获得肺动脉高压新药；Gilead Sciences以78亿美元增持其CAR-T合作伙伴Arcellx；礼来以24亿美元收购Orna Therapeutics。在大型药企纷纷补强管线的背景下，拥有差异化技术和晚期临床资产的biotech正在成为争夺焦点。Aicuris凭借已上市产品的现金流和临近获批的III期资产，成为旭化成战略版图中的理想拼图。声明：文章中的信息仅供一般参考之用，不可直接作为决策内容。蒲公英资讯 | 更懂制药人专注医药产业与行业技术；提供深度资讯、专业咨询、媒体宣传与资源链接；助力企业把握行业脉搏，链接产业价值。欢迎合作交流：孟女士 18810836617 蒲公英资讯 END 点击名片欢迎关注我们

100 项与 Aicuris Anti-Infective Cures AG 相关的药物交易

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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	骨髓移植排斥反应更多	临床1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