WUPPERTAL, Germany--(BUSINESS WIRE)--AiCuris Anti-infective Cures AG, announced today multiple milestone achievements for letermovir (marketed by MSD as PREVYMIS®) and across its pipeline of anti-viral therapeutics serving the growing population of people whose immune systems are impacted due to disease or immunosuppressive therapies.

德国WUPPERTAL——（商业新闻短讯）——爱库里斯抗感染治疗公司（AiCuris Anti infective Cures AG）今天宣布了莱特莫韦（由MSD以PREVYMIS®销售）的多项里程碑式成就，以及为越来越多的免疫系统因疾病或免疫抑制疗法而受到影响的人群提供抗病毒治疗的渠道。

These achievements recognize AiCuris’ rapid progress in developing a clinical pipeline of precise therapies to effectively treat infections in a population for whom an otherwise manageable infection, can mean life or death..

这些成就认可了爱库里斯在开发精确疗法的临床管道方面取得的快速进展，该疗法可以有效治疗人群中的感染，而对于这些人群来说，原本可以控制的感染可能意味着生命或死亡。。

“Our mission is to make a difference for people with weakened immune systems, by giving them options in preventing or treating infections that are life-threatening for them. The expanded approval of PREVYMIS® in Japan highlights its unique drug profile in diverse transplant settings where CMV infections pose a significant risk to adult patients on immunosuppressive therapies.

“我们的使命是通过为免疫系统受损的人提供预防或治疗威胁其生命的感染的选择，为他们带来不同。PREVYMIS®在日本的扩大批准突显了其在CMV感染对接受免疫抑制治疗的成年患者构成重大风险的各种移植环境中的独特药物特征。

Combined with the existing approvals in the U.S. and Europe, it provides further validation for the outstanding drug development capabilities of the AiCuris team and the benefit PREVYMIS® can provide for immunocompromised patients,” said Larry Edwards, CEO of AiCuris. “It is our goal to achieve the same level of success for patients with our two follow-on pipeline programs pritelivir, which is close to pivotal Phase 3 read-out, and AIC468’s first-in-human study starting in the near-term.”.

结合美国和欧洲现有的批准，它进一步验证了AiCuris团队出色的药物开发能力，以及PREVYMIS®可以为免疫功能低下的患者提供的益处，”AiCuris首席执行官拉里·爱德华兹（Larry Edwards）说。“我们的目标是通过我们的两个后续管道项目pritelivir（接近关键的第三阶段读数）和AIC468近期开始的首次人体研究，为患者取得同样水平的成功。”。

PREVYMIS® Update

演示® 更新

In May, PREVYMIS® (letermovir) achieved approval in Japan for the use in adult patients receiving solid organ transplants (SOT). This significant milestone represents the first pan transplant indication approval for PREVYMIS®, a first-in-class antiviral agent commercialized by our partner MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant and prophylaxis of CMV in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).

5月，PREVYMIS®（莱特莫韦）在日本获得批准，用于接受实体器官移植（SOT）的成年患者。这一重要里程碑代表了PREVYMIS®的首次泛移植适应症批准，PREVYMIS®是由我们的合作伙伴MSD（Merck＆Co.，Inc.，Rahway，N.J.，USA）商业化的一流抗病毒药物，用于预防巨细胞病毒（CMV）感染和异基因造血干细胞移植的成人CMV血清阳性受体[R+]的疾病，以及预防高危成人肾移植受者的CMV（供体CMV血清阳性/受体CMV血清阴性[D+/R-]）。

PREVYMIS® is marketed in over 60 countries. Following this achievement, AiCuris will receive a milestone payment of EUR €7.5 million from MSD..

PREVYMIS®在60多个国家销售。取得这一成就后，爱库里斯将从MSD获得750万欧元的里程碑付款。。

Pipeline Updates

管道更新

AiCuris published pharmacokinetic data for its lead candidate pritelivir (AIC316), an innovative therapeutic candidate targeting HSV replication, in May 2024. Pritelivir is currently being evaluated in a Phase 3 trial for the treatment of acyclovir-resistant HSV infections in immunocompromised patients.

AiCuris于2024年5月发布了其主要候选药物普瑞替利韦（AIC316）的药代动力学数据，这是一种针对HSV复制的创新治疗候选药物。Pritelivir目前正在一项3期临床试验中进行评估，用于治疗免疫功能低下患者的阿昔洛韦耐药HSV感染。

The study expects to complete patient enrollment in 1H 2025. The study titled “Evaluation of the Clinical Drug-Drug Interaction Potential of Pritelivir on Transporters and CYP450 Enzymes Using a Cocktail Approach” was recently published in the journal Clinical Pharmacology in Drug Development and provides data on the drug-drug interaction profile of pritelivir.

该研究预计在2025年上半年完成患者登记。这项题为“使用鸡尾酒方法评估普瑞替韦对转运蛋白和CYP450酶的临床药物相互作用潜力”的研究最近发表在《药物开发中的临床药理学》杂志上，并提供了普瑞替韦的药物相互作用概况的数据。

The results demonstrated that pritelivir has a low risk of drug-drug interaction, as there was no effect on intestinal uptake and efflux transporters. These findings are crucial for ensuring the safety and efficacy of pritelivir as a treatment option for patients with resistant HSV infections, who are often receiving a range of additional treatments..

结果表明，普瑞替韦具有较低的药物相互作用风险，因为对肠道摄取和外排转运蛋白没有影响。这些发现对于确保pritelivir作为耐药HSV感染患者的治疗选择的安全性和有效性至关重要，这些患者经常接受一系列额外的治疗。。

In addition, AiCuris’ third pipeline candidate AIC468 is rapidly nearing the clinic after the regulatory approval of its clinical trial application by the German national authority. AIC468, an antisense RNA therapeutic candidate, is designed to treat BK virus (BKV) infection, which can lead to BKV-associated nephropathy, increasing the risk of chronic kidney failure or graft loss.

此外，在德国国家管理局批准其临床试验申请后，爱库里斯的第三个候选管道AIC468正在迅速接近诊所。AIC468是一种反义RNA治疗候选物，旨在治疗BK病毒（BKV）感染，这可能导致BKV相关性肾病，增加慢性肾衰竭或移植物丢失的风险。

AIC468 will be investigated in a first-in-human Phase 1 trial in healthy volunteers starting in Q3 of 2024. Up to 88 healthy individuals are expected to be enrolled in multiple single and multi-ascending dose cohorts with the objective to investigate safety and tolerability of AIC468. AIC468 specifically inhibits BKV replication, addressing the critical need to target the virus directly.

AIC468将于2024年第三季度开始在健康志愿者中进行首次人体1期试验。预计多达88名健康个体将参加多个单剂量和多剂量递增队列，目的是调查AIC468的安全性和耐受性。AIC468特异性抑制BKV复制，解决了直接靶向病毒的关键需求。

By not compromising ongoing immunosuppressive treatments - the current standard of care – it helps to reduce the risk of graft loss. Preclinical studies have shown AIC468's mechanism of action effectively inhibits BKV replication in human kidney cells and achieved efficacious concentrations in kidney tissues in vivo.

通过不影响正在进行的免疫抑制治疗（目前的护理标准），它有助于降低移植物丢失的风险。临床前研究表明，AIC468的作用机制可有效抑制人肾细胞中的BKV复制，并在体内肾组织中达到有效浓度。

Additionally, a favorable pharmacokinetic and safety profile as well as a broad therapeutic window could be demonstrated preclinically warranting the start of clinical development..

此外，可以在临床前证明有利的药代动力学和安全性以及广泛的治疗窗口，从而保证临床开发的开始。。

“AiCuris is driving innovation in antiviral therapies with our pipeline candidates pritelivir and AIC468. The recent publication on pritelivir underscores its potential as a breakthrough treatment for acyclovir-resistant HSV infections for immunocompromised patients,” said Larry Edwards. “Additionally, achieving Phase 1 approval for AIC468 marks a significant milestone in our efforts to address BK virus infections, showcasing promising preclinical efficacy data.

“AiCuris正在利用我们的候选药物pritelivir和AIC468推动抗病毒治疗的创新。拉里·爱德华兹（LarryEdwards）说：“最近关于普瑞替利韦的出版物强调了其作为免疫功能低下患者阿昔洛韦耐药HSV感染突破性治疗的潜力。”。“此外，获得AIC468的第一阶段批准标志着我们努力解决BK病毒感染的一个重要里程碑，展示了有希望的临床前疗效数据。

We look forward to the upcoming data from these programs which will be important steppingstones in developing novel therapies for immunocompromised people.”.

我们期待着这些计划即将提供的数据，这将是为免疫功能低下的人开发新疗法的重要步骤。”。

About Prevymis®

关于Prevymis®

PREVYMIS® (letermovir), developed by AiCuris and marketed by MSD, is indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant and prophylaxis of CMV in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-].

PREVYMIS®（letermovir）由AiCuris开发并由MSD销售，用于预防异基因造血干细胞移植的成人CMV血清阳性受体[R+]的CMV感染和疾病，以及预防高危成人肾移植受者的CMV（供体CMV血清阳性/受体CMV血清阴性[D+/R-]）。

The drug is marketed in more than 60 countries outside the U.S., including in the E.U., Canada, Japan and China, and has received approval for prevention of CMV infections in adult solid organ transplant (SOT) recipients in Japan in 2024. The recent approval for SOT in Japan is supported by robust clinical trials demonstrating its efficacy and safety in preventing CMV disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative)..

该药物在美国以外的60多个国家销售，包括欧盟、加拿大、日本和中国，并于2024年获得批准用于预防日本成人实体器官移植（SOT）受者的CMV感染。最近在日本批准的SOT得到了强有力的临床试验的支持，这些试验证明了其在预防高危成人肾移植受者（供体CMV血清阳性/受体CMV血清阴性）CMV疾病方面的有效性和安全性。。

About Pritelivir

关于Pritelivir

Pritelivir, a novel helicase-primase inhibitor developed by AiCuris, targets both HSV-1 and HSV-2. These viruses are responsible for genital, oral or disseminated infections with increasing severity and resistance development in immunocompromised people. Unlike traditional antivirals, pritelivir blocks viral DNA synthesis by inhibiting the helicase-primase complex, a mechanism distinct from nucleoside analogues like acyclovir.

。这些病毒导致生殖器，口腔或播散性感染，免疫功能低下的人的严重程度和耐药性增加。与传统抗病毒药物不同，普利韦通过抑制解旋酶-引物复合物来阻断病毒DNA的合成，这种机制不同于核苷类似物如阿昔洛韦。

Earlier Phase 1 and Phase 2 trials in immune competent and immune compromised individuals showed a favorable safety profile and an improved clinical efficacy compared with standard of care treatments like valaciclovir and Foscarnet (including resistant or intolerant infections). Recognized with Breakthrough Therapy designation by the FDA for immunocompromised patients, pritelivir is currently advancing through a pivotal Phase 3 trial.

与伐昔洛韦和膦甲酸钠（包括耐药性或不耐受性感染）等标准治疗相比，免疫功能正常和免疫功能低下个体的早期1期和2期试验显示出良好的安全性和改善的临床疗效。美国食品和药物管理局（FDA）为免疫功能低下患者指定了突破性治疗方案，pritelivir目前正在进行一项关键的3期临床试验。

The results of this trial will serve as a basis for filing for marketing authorization in 2026..

该试验结果将作为2026年申请上市许可的依据。。

About AIC468

关于AIC468

AIC468 is a pioneering RNA-based therapy designed to treat BK virus (BKV) reactivation in kidney transplant patients. BKV infections prove to be a significant clinical challenge, particularly for kidney transplant recipients, as they can lead to BKV-associated nephropathy, resulting in chronic kidney failure or graft loss.

AIC468是一种开创性的基于RNA的疗法，旨在治疗肾移植患者的BK病毒（BKV）再激活。BKV感染被证明是一个重大的临床挑战，特别是对于肾移植受者来说，因为它们可能导致BKV相关的肾病，导致慢性肾衰竭或移植物丢失。

To date, there are no approved antiviral treatments for BKV; the only option is to reduce immunosuppression therapy, increasing the risk of graft rejection. AIC468 is an antisense oligonucleotide that targets viral replication within infected cells by inhibiting the splicing of mRNA coding for the BKV master regulator large T-antigen.

迄今为止，还没有批准的BKV抗病毒治疗方法；唯一的选择是减少免疫抑制治疗，增加移植物排斥的风险。AIC468是一种反义寡核苷酸，通过抑制编码BKV主调节因子大T抗原的mRNA的剪接来靶向感染细胞内的病毒复制。

This innovative approach has demonstrated favorable pharmacokinetics and significant inhibition of BKV replication in preclinical studies. AiCuris expects to initiate the first human trial for AIC468 in Q3 of 2024, aiming to provide a much-needed therapeutic option for kidney transplant patients at risk of BKV reactivation..

这种创新方法在临床前研究中证明了有利的药代动力学和对BKV复制的显着抑制。AiCuris预计将于2024年第三季度启动AIC468的首次人体试验，旨在为有BKV再激活风险的肾移植患者提供急需的治疗选择。。

About Herpes Simplex Virus

关于单纯疱疹病毒

Herpes Simplex Virus (HSV) includes two types, HSV-1 and HSV-2, both of which cause lifelong infections. HSV-1 typically leads to oral herpes, resulting in cold sores around the mouth, while HSV-2 is commonly associated with genital herpes. These viruses can cause recurrent painful blisters and sores, and in severe cases, complications such as encephalitis, disseminated disease and neonatal herpes.

单纯疱疹病毒（HSV）包括两种类型，HSV-1和HSV-2，两者都会导致终身感染。HSV-1通常会导致口腔疱疹，导致口腔周围出现寒疮，而HSV-2通常与生殖器疱疹有关。这些病毒可引起反复出现的疼痛性水疱和溃疡，严重时可引起脑炎、播散性疾病和新生儿疱疹等并发症。

HSV infections are widespread globally, with a significant impact on public health, especially immunocompromised patients, due to their high prevalence, more severe and more frequent manifestations and increased potential for drug resistance..

HSV感染在全球范围内广泛存在，由于其高流行率，更严重和更频繁的表现以及增加的耐药性潜力，对公众健康，尤其是免疫功能低下的患者产生了重大影响。。

About BK Virus

关于BK病毒

BK virus (BKV) is a polyomavirus that commonly infects the urinary tract. While it remains latent in most healthy individuals, it can reactivate in immunocompromised patients, such as those undergoing organ transplantation. Reactivation of BKV can lead to serious complications, including BK virus-associated nephropathy (BKVN), which can cause kidney dysfunction and graft loss in transplant recipients.

BK病毒（BKV）是一种多瘤病毒，通常感染泌尿道。虽然它在大多数健康个体中仍然潜伏，但它可以在免疫功能低下的患者（例如接受器官移植的患者）中重新激活。BKV的再激活可导致严重的并发症，包括BK病毒相关性肾病（BKVN），其可导致移植受者的肾功能障碍和移植物丢失。

Managing BKV infections is essential in immunocompromised patients to prevent significant morbidity and improve transplant outcomes..

管理BKV感染对于免疫功能低下的患者至关重要，以防止严重的发病率并改善移植结果。。

About AiCuris

关于爱库里斯

AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS®, marketed by our partner MSD, prevents CMV in a defined group of transplant recipients. Our pivotal Phase 3 candidate pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems.

艾库里斯正在满足日益增长的免疫功能低下人群的需求，这些人群需要精确的疗法来有效治疗感染。我们的旗舰产品PREVYMIS®由我们的合作伙伴MSD销售，可预防特定移植受者群体中的CMV。我们关键的3期候选药物普利韦旨在解决免疫系统减弱的广大患者中复发性和耐药性HSV感染的问题。

For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future..

对于免疫功能低下的人来说，原本可以控制的感染可能意味着生命或死亡。爱库里斯凭借其专业知识和不断增长的渠道，致力于现在和未来为他们提供治疗解决方案。。