SIFI宣布与加州大学旧金山分校就棘阿米巴角膜炎展开合作-动脉网

SIFI announces collaboration with the University of California, San Francisco on Acanthamoeba Keratitis

CISION 等信源发布 2025-03-18 19:59

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The

University of California San Francisco

加利福尼亚大学旧金山分校

is coordinating the Parasitic Ulcer Treatment Trial, a study aimed at understanding the role of topical corticosteroids after initiation of anti-amoebic therapy

正在协调寄生虫溃疡治疗试验，这是一项旨在了解在开始抗阿米巴治疗后局部使用皮质类固醇的作用的研究。

SIFI is supporting the trial with its proprietary polihexanide 0.08%, commercially available in

SIFI公司正在通过其专有的0.08%聚己烷基双胍（polihexanide）支持该试验，该产品已上市销售。

Europe

欧洲

since

自从

October 2024

2024年10月

under the brand name Akantior®

品牌名称 Akantior®

The first US patient was dosed on

美国首位患者已给药

March 6, 2025

2025年3月6日

with SIFI's polihexanide 0.08%

使用SIFI的聚己亚甲基0.08%

CATANIA,

卡塔尼亚，

Italy

意大利

，

March 18, 2025

2025年3月18日

/PRNewswire/ -- SIFI, a leading international pharmaceutical company specializing in ophthalmology, is pleased to announce a scientific collaboration with the

/PRNewswire/ -- SIFI，一家专注于眼科的国际领先制药公司，欣然宣布与

University of California, San Francisco

加利福尼亚大学旧金山分校

('UCSF') aimed at improving the management of Acanthamoeba Keratitis ('AK').

('UCSF') 旨在改善棘阿米巴角膜炎 ('AK') 的管理。

The Parasitic Ulcer Treatment Trial ('PUTT') is an investigator-initiated study led by Dr.

寄生虫溃疡治疗试验（“PUTT”）是一项由研究者发起的研究，由博士领导。

Jeremy Keenan

杰里米·基南

, Professor of Ophthalmology at UCSF, and performed at multiple sites across

，加州大学旧金山分校眼科教授，并在多个地点进行过表演

the United States of America

美国

，

Brazil

巴西

，

India

印度

and the

和

United Kingdom

英国

, with the objective of enrolling 232 patients. The primary objective of this multicenter, randomized controlled trial is to determine whether patients who start topical corticosteroids 1 month after beginning an anti-acanthamoebic regimen will have better visual acuity at 6 months compared to patients given a placebo eyedrop..

，目标是招募232名患者。这项多中心随机对照试验的主要目的是确定在开始抗棘阿米巴治疗方案1个月后使用局部皮质类固醇的患者，与使用安慰剂滴眼液的患者相比，在6个月时是否会有更好的视力。

SIFI received a Marketing Authorization from the European Commission for Akantior® (polihexanide 0.08%) in

SIFI收到了欧洲委员会关于Akantior®（聚己亚甲基双胍0.08%）的上市授权，

August 2024

2024年8月

after over 15 years of research and development. Its approval was supported by the ODAK trial, the largest Phase 3 study ever conducted for AK, which demonstrated high cure rates and set a new standard of care. SIFI holds international patents on Akantior®, including the US application 2023/0263824..

经过了超过15年的研发。其批准得到了ODAK试验的支持，这是迄今为止针对角膜炎（AK）进行的最大规模的第三阶段研究，该试验展示了高治愈率并设定了新的护理标准。SIFI拥有Akantior®的国际专利，包括美国专利申请2023/0263824。

Polihexanide 0.08%, not yet commercially available outside the European Economic Area, will be accessible for AK patients being enrolled in the PUTT at the following sites:

聚己烷基胍0.08%，在欧洲经济区以外尚未上市，将为参加PUTT的AK患者在以下地点提供：

Francis I. Proctor Foundation at the

法兰西斯一世。普罗克特基金会位于

University of California, San Francisco

加利福尼亚大学，旧金山分校

(

USA

美国

)

Eye and Ear Infirmary at the

眼耳疗养院位于

University of Illinois at Chicago

伊利诺伊大学芝加哥分校

(

USA

美国

)

Jules Stein Eye Institute at

朱尔斯·斯坦眼科研究所位于

University of California, Los Angeles

加利福尼亚大学洛杉矶分校

(

USA

美国

)

Bascom Palmer Eye Institute at the

巴斯康姆·帕尔默眼科研究所位于

University of Miami

迈阿密大学

(

USA

美国

)

Wilmer Eye Institute at

威尔默眼科研究所位于

Johns Hopkins University

约翰霍普金斯大学

(

USA

美国

)

Casey Eye Institute at Oregon Health Science University (

凯西眼科研究所，位于俄勒冈健康科学大学（

USA

美国

)

University of Pennsylvania

宾夕法尼亚大学

(

Philadelphia, Pennsylvania

宾夕法尼亚州费城

, USA)

，美国）

University of Iowa

爱荷华大学

(USA)

（美国）

Columbia University

哥伦比亚大学

(

USA

美国

)

University of Florida

佛罗里达大学

(USA)

（美国）

São Paulo Hospital at the Federal University of

圣保罗医院在联邦大学

Sao Paulo

圣保罗

(

Brazil

巴西

)

Moorfields Eye Hospital (

摩菲眼科医院 (

England

英格兰

)

Aravind Eye Care System (

Aravind眼科护理系统 (

India

印度

)

在

March 6

3月6日

, the first US patient was dosed at UCSF with SIFI's Polihexanide 0.08% under the study protocol.

，第一名美国患者在UCSF按照研究方案接受了SIFI的0.08%聚己双胍治疗。

Prof.

教授

Jeremy Keenan

杰里米·基南

, Principal Investigator at UCSF, commented:

加州大学旧金山分校 (UCSF) 首席研究员评论道：

'The PUTT trial is designed to make an evidence-based contribution to an important debate in the management of AK: the use of adjunctive corticosteroid eyedrops alongside an effective antiamoebic treatment. AK is a rare but very severe ocular infection that can potentially lead to blindness and requires urgent treatment. Using a high-concentration, more potent anti-amoebic eyedrop produced in accordance with pharmaceuticals' good manufacturing practices, instead of the lower concentrations typically ordered from compounding pharmacies, will allow us to more cleanly study the anti-inflammatory effect of adjunctive corticosteroid eyedrops, reducing variability arising from the use of compounded formulations across multiple clinical sites.'.

“PUTT试验旨在为AK管理中的一个重要争论提供基于证据的贡献：在有效的抗阿米巴治疗中辅以皮质类固醇滴眼液的使用。AK是一种罕见但非常严重的眼部感染，可能导致失明，需要紧急治疗。使用高浓度、更强效的、按照药品良好生产规范生产的抗阿米巴滴眼液，而非通常由复合药房配制的较低浓度药物，这将使我们能够更清晰地研究辅助皮质类固醇滴眼液的抗炎效果，减少因在多个临床地点使用复合配方而产生的变异性。”

Fabrizio Chines, CEO of SIFI, added:

SIFI首席执行官法布里齐奥·奇内斯补充道：

'At SIFI, patients always come first. We strive to improve access to our most effective treatment for AK worldwide. Whilst we continue our engagement with the FDA to submit a New Drug Application for Akantior® later this year, we are delighted to support Prof. Keenan and the other investigators of the PUTT trial with our proprietary GMP-grade Polihexanide 0.08%.

“在SIFI，患者始终是第一位的。我们致力于在全球范围内改善AK最有效治疗的可及性。在我们继续与FDA合作，计划在今年晚些时候提交Akantior®的新药申请的同时，我们很高兴能够为PUTT试验的基南教授及其他研究者提供我们专有的GMP级0.08%聚己双胍支持。

It is great to see that the first patient in the US has received our drug, after many years of R&D investments. I also hope this is the beginning of fruitful collaborations in rare corneal infections, as we advance the clinical development of Polihexanide in Fungal Keratitis, following the Orphan Drug Designations received in the .

很高兴看到美国的首位患者在多年研发投入后接受了我们的药物。我也希望这是在罕见角膜感染领域富有成效的合作的开始，因为我们将在获得孤儿药资格后，继续推进聚六亚甲基双胍在真菌性角膜炎中的临床开发。

USA

美国

and

和

Europe

欧洲

ABOUT AKANTIOR

关于AKANTIOR

: AKANTIOR (polihexanide 0.08%) is the first and only approved drug for the treatment of AK in the world. It is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml (0.08%) concentration which makes it possible to administer as monotherapy eye drops in single-dose containers..

：AKANTIOR（聚己烷啶 0.08%）是全球首个且唯一获批用于治疗棘阿米巴角膜炎（AK）的药物。它是一种抗阿米巴聚合物，对原生动物棘阿米巴的滋养体和包囊均有效。其配方浓度为0.8毫克/毫升（0.08%），可以单剂量容器中的单一疗法滴眼液形式给药。

ABOUT AK

关于AK

: AK is an ultra-rare, acute, severe parasitic corneal infection caused by acanthamoeba, a free-living amoeba. Incidence in the

：AK 是一种由自由生活的阿米巴原虫引起的超罕见、急性、严重的寄生性角膜感染。其发病率在

USA

美国

has been estimated at 2,600 new cases per year. AK is an ocular emergency and requires urgent treatment to save the eye. It can lead to poor vision, potential blindness, or even eye loss and often requires single or multiple corneal transplants. It affects people of all ages, most of whom are young or middle-aged soft contact lens wearers.

每年约有 2,600 例新病例。AK 是一种眼科急症，需要紧急治疗以挽救视力。它可能导致视力下降、潜在性失明甚至眼球丧失，并且通常需要进行单次或多次角膜移植。这种疾病影响所有年龄段的人群，其中大多数是年轻或中年的软性隐形眼镜佩戴者。

Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve..

患者报告称无法忍受的疼痛和极度的光敏感，几乎无法工作或过正常的生活，直到症状缓解。

ABOUT UCSF:

关于UCSF:

The

University of California, San Francisco

加利福尼亚大学旧金山分校

(UCSF) is a world-renowned medical institution dedicated to research, education, and patient care. The UCSF Department of Ophthalmology is at the forefront of vision research and clinical innovation, working to improve treatment outcomes for rare and severe eye diseases.

加州大学旧金山分校（UCSF）是一家世界知名的医疗机构，致力于研究、教育和患者护理。UCSF眼科系在视力研究和临床创新方面处于前沿，努力改善罕见和严重眼疾的治疗效果。

ABOUT

关于

SIFI:

系统重要性金融机构：

SIFI is a leading international ophthalmic company, headquartered in Italy, featuring an integrated business model, from research & development to manufacturing and commercialization both in pharmaceutical and biomedical sectors. Since our foundation in 1935, our mission is to improve people's lives through meaningful innovation in eye care.

SIFI是一家领先的国际眼科公司，总部位于意大利，业务模式涵盖从研发到制药和生物医学领域的生产和商业化。自1935年成立以来，我们的使命是通过在眼科护理领域的有意义创新来改善人们的生活。

SIFI exports to more than 60 Countries worldwide with a direct presence in major European markets, Mexico and, through joint ventures, in China and the United Arab Emirates. More information available at .

SIFI出口到全球60多个国家，在欧洲主要市场、墨西哥有直接业务，并通过合资企业进入中国和阿联酋市场。更多信息请访问。

www.sifigroup.com

The information stated above was prepared by SIFI and reflects solely the opinion of SIFI. Nothing in this statement shall be construed to imply any support or endorsement of SIFI or any of its products by the

上述信息由SIFI编制，仅代表SIFI的意见。本声明中的任何内容均不应被解释为暗示对SIFI或其任何产品的支持或认可。

Regents

校董会成员

of the

的

University of California

加利福尼亚大学

, its officers, agents and employees. Prof. Keenan will not receive any compensation from SIFI on this research program.

，其官员、代理人和雇员。基南教授将不会从SIFI获得此研究计划的任何报酬。

SOURCE SIFI S.p.A.

来源：SIFI S.p.A.

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