AKAGERA医药公司宣布完成用于治疗肺结核的静脉注射AKG-100一期研究的首个队列-动脉网

AKAGERA Medicines, Inc. announces the completion of the first cohort in the IV AKG-100 phase 1 study for the treatment of pulmonary tuberculosis.

CISION 等信源发布 2025-04-01 21:30

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可切换为仅中文





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KIGALI, Rwanda

基加利，卢旺达

and

和

WALTHAM, Mass.

马萨诸塞州沃尔瑟姆

，

April 1, 2025

2025年4月1日

/PRNewswire/ -- AKAGERA Medicines, Inc. is a biotech company focused on the discovery and development of novel lipid nanoparticle formulations of antibacterial drugs and mRNA vaccines to treat tuberculosis, avian flu, RSV and other infectious diseases. The company announced today that it completed the first cohort in its first-in-human phase 1 SAD/MAD study of AKG-100, which is an oxazolidinone class of antibiotic for treatment of pulmonary tuberculosis (TB)..

/PRNewswire/ -- AKAGERA医药公司是一家生物技术公司，专注于发现和开发新型抗菌药物和mRNA疫苗的脂质纳米颗粒制剂，用于治疗结核病、禽流感、呼吸道合胞病毒（RSV）及其他传染病。该公司今天宣布，已完成其首个针对人类的1期单剂量递增/多剂量递增（SAD/MAD）研究的第一组受试者试验，该试验涉及的AKG-100属于恶唑烷酮类抗生素，用于治疗肺结核（TB）。

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AKAGERA Medicines is substantially supported by the Coalition for Epidemic Preparedness Innovations (CEPI) in

阿卡吉拉医药公司得到了流行病防范创新联盟（CEPI）的大力支持。

Norway

挪威

, the Bill and Melinda Gates Foundation, the National Institute of Health (NIH) in

，比尔和梅琳达·盖茨基金会，美国国立卫生研究院（NIH）在

Washington

华盛顿

, and the European Investment Bank (EIB) in

，以及欧洲投资银行（EIB）在

Luxembourg

卢森堡

。

Despite being preventable and treatable, TB is the leading infectious disease killer and a major global health threat.

尽管结核病可防可治，但它仍是头号传染病杀手，也是全球健康的重大威胁。

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The study consists of single ascending dosing (SAD) and multiple ascending dosing (MAD) to establish the safety and pharmacokinetics of AKG-100 alone in single doses in healthy volunteers and pulmonary TB patients as well as in multiple doses in pulmonary TB patients. This study is being conducted at TASK clinical research site in .

本研究包括单剂量递增（SAD）和多剂量递增（MAD），以评估AKG-100在健康志愿者和肺结核患者中的单次给药安全性及药代动力学，以及在肺结核患者中的多次给药情况。这项研究正在TASK临床研究站点进行。

Cape Town, South Africa

南非开普敦

. Approximately 100 participants will be enrolled in the study.

大约100名参与者将被纳入研究。

'The completion of the first cohort in this study is an important milestone as we progress a novel long-acting injectable and targeted treatment option for patients with pulmonary TB,' said

“这项研究中第一个队列的完成是一个重要的里程碑，因为我们正在推进一种新型的长效注射和针对肺结核患者的治疗选择，”表示

Dr.

博士

Daryl Drummond

达里尔·德拉蒙德

, Chief Science Officer of AKAGERA Medicines

，AKAGERA医药公司的首席科学官

. He added, 'AKG-100 demonstrated promising preclinical data, and we believe that the addition of AKG-100 to drug-resistant TB treatment regimens will improve anti-TB activity and provide a favorable safety profile.' Less frequent IV dosing is also expected to provide flexibility and improve treatment compliance in the poorest countries in the world..

他补充说：‘AKG-100展示了令人鼓舞的临床前数据，我们相信将AKG-100加入耐药结核病治疗方案将提高抗结核活性，并提供良好的安全性。’ 较低频率的静脉注射剂量也有望为世界上最贫困的国家提供灵活性并改善治疗依从性。

'TB is the greatest killer in human history. One out of seven people who ever lived has died from it. Nearly, two million of the poorest people in

“结核病是人类历史上最大的杀手。每七个人中就有一人死于该病。近两百万最贫穷的人们因此丧生。

Russia

俄罗斯

，

India

印度

，

Africa

非洲

, and

，以及

China

中国

die from it every year and 400,000 of them are children,' said

每年因此死亡，其中40万人是儿童，”

Michael Fairbanks

迈克尔·费尔班克斯

, Executive Chairman of AKAGERA Medicines

阿卡盖拉医药公司的执行主席

。

About AKG-100:

关于AKG-100:

AKG-100 is a highly stabilized pegylated liposomal formulation of a novel oxazolidinone antibiotic. 'Liposome-encapsulated drugs are a promising area of drug delivery research that involves the use of microscopic lipid-based vesicles to transport drugs to target cells or tissues,' said,

AKG-100是一种新型恶唑烷酮类抗生素的高度稳定的聚乙二醇化脂质体制剂。 “脂质体 encapsulated 药物是药物递送研究中一个有前景的领域，它涉及使用基于显微脂质的囊泡将药物运输到目标细胞或组织，”他表示。

Dr. Sachin Marulkar, the Chief Medical Officer of AKAGERA Medicines

AKAGERA医药公司的首席医疗官萨钦·马鲁尔卡尔博士

. He added, 'The AKG-100 liposome encapsulated formulation enhances drug efficacy by increasing drug stability, improving drug solubility, and reducing toxicity.' AKG-100 also increases drug uptake and retention by target cells and leads to higher drug concentrations at the site of action. Liposomes protect drugs from degradation, clearance, or immune recognition, and allow for sustained drug release and longer circulation times..

他补充说：“AKG-100脂质体封装制剂通过提高药物稳定性、改善药物溶解性和降低毒性来增强药效。” AKG-100还增加了靶细胞对药物的摄取和保留，从而在作用部位达到更高的药物浓度。脂质体保护药物免于降解、清除或免疫识别，并实现持续药物释放和更长的循环时间。

About AKAGERA Medicines:

关于AKAGERA药品：

AKAGERA Medicines develops novel liposomal formulations of drugs to treat tuberculosis, and mRNA vaccines to prevent infection by RSV, influenza, avian flu, Lassa Fever, tuberculosis, and HIV.

AKAGERA医药公司开发了用于治疗结核病的新型脂质体药物配方，以及预防RSV、流感、禽流感、拉沙热、结核病和艾滋病感染的mRNA疫苗。

The clinical stage company was founded in 2018 in

这家临床阶段的公司成立于2018年

Kigali, Rwanda

卢旺达，基加利

. It is registered as a

。它被注册为一个

Delaware

特拉华州

corporation and has laboratories in

公司并在以下地方设有实验室

Boston

波士顿

and

和

San Francisco

旧金山

. It is well-funded, majority-owned by the people of

. 该机构资金充足，大部分由民众持有

Rwanda

卢旺达

through the Rwanda Social Security Board (RSSB). Akagera Medicines registered a 100%-owned subsidiary in

通过卢旺达社会保障局 (RSSB)。阿卡盖拉医药注册了一家全资子公司在

Kigali

基加利

in 2022 to do manufacturing and clinical trials.

2022年进行生产和临床试验。

Founding and current board members include Ambassador Dr.

创始成员和现任董事会成员包括大使博士。

Albrecht Conze

阿尔布雷希特·孔策

, Dr.

，博士。

Paul Farmer

保罗·法默

的

Harvard Medical School

哈佛医学院

, Dr.

，博士。

Donald Kaberuka

唐纳德·卡贝鲁卡

, former Chair of the Global Fund for Malaria, HIV and Tb and past president of the African Development Bank; Dr.

，全球抗击艾滋病、结核病和疟疾基金前主席，非洲开发银行前行长；博士。

Eliane Ubalijoro

埃利安·乌巴利若罗

的

McGill University

麦吉尔大学

and CEO of CIFOR-ICRAF; UN Ambassador

CIFOR-ICRAF首席执行官；联合国大使

Valentine Rugwabiza

瓦伦丁·鲁瓜比扎

;

；

Philippe Watrin

菲利普·瓦特兰

, the Chief Investment Officer of the RSSB; and Dr. Patrick Migambi,

RSSB的首席投资官；以及帕特里克·米甘比博士，

Rwanda's

卢旺达的

TB specialist.

结核病专家。

Michael Fairbanks

迈克尔·费尔班克斯

is the executive chairman and co-founder. Dr.

是执行主席和联合创始人。博士。

Daryl Drummond

达里尔·德拉蒙德

and Dr. Dimitri Kirpotin are co-founders who translated their successful delivery system from pancreatic cancer to infectious diseases. Dr. Sachin Marulkar is the chief medical officer and oversees the clinical development and trial activities.

德米特里·基尔波京博士是将他们成功的胰腺癌递送系统应用于传染病的共同创始人。萨钦·马鲁尔卡尔博士是首席医疗官，负责监督临床开发和试验活动。

About TASK Clinical Research:

关于TASK临床研究：

TASK is a multinational, multi-site clinical research institute headquartered in

TASK是一家总部位于多国、多地点的临床研究机构

Cape Town, South Africa

南非开普敦

. TASK provides clinical trial services for phase I to phase IV studies. They have completed over 100 studies with a focus on infectious diseases including TB. TASK is led by Prof.

TASK提供从I期到IV期临床试验的服务。他们已经完成了100多项研究，重点关注包括结核病在内的传染病。TASK由教授领导。

Andreas Diacon

安德烈亚斯·迪亚康

who was awarded the 2016 Scientific Prize of the International Union Against Tuberculosis and Lung Disease. He has been recognized by Gates Foundation for his contribution in the TB field.

谁被授予2016年国际抗结核和肺病联合会科学奖。他因在结核病领域的贡献而受到盖茨基金会的认可。

About Tuberculosis:

关于结核病：

TB is a social disease that undermines civilization. Despite being preventable and treatable, TB is the leading infectious disease killer and continues to be a major global health threat. TB is significantly linked to socio-economic determinants – the most vulnerable population are those living in poor and crowded conditions; those living with HIV, malnutrition, alcohol abuse, diabetes; and refugees, prisoners and the destitute.

结核病是一种破坏文明的社会疾病。尽管结核病可防可治，但它仍然是导致死亡的最主要的传染病，并持续构成重大的全球健康威胁。结核病与社会经济决定因素显著相关——最脆弱的人群是那些生活在贫困和拥挤环境中的人；那些感染艾滋病毒、营养不良、酗酒、糖尿病的人；以及难民、囚犯和赤贫者。

。

Michael Fairbanks

迈克尔·费尔班克斯

said, 'Though barely a talking point in the capitals of the west, it is a feature of our global culture, one that destroys the hopes and aspirations of millions of people in the Majority World.'

说：「虽然在西方国家的首都几乎没有人谈论这个问题，但它是我们的全球文化的一个特征，它摧毁了多数世界中数百万人的希望和愿望。」

Over 95% of deaths are in poor countries. 'Eight countries account for two thirds of the total with

超过95%的死亡发生在贫穷国家。 ‘八个国占了总数的三分之二，

India

印度

leading in deaths, followed by

在死亡方面居首位，其次是

China

中国

，

Indonesia

印度尼西亚

，

the Philippines

菲律宾群岛

，

Pakistan

巴基斯坦

，

Nigeria

尼日利亚

，

Bangladesh

孟加拉国

and

和

South Africa

南非

,' said Dr. Marulkar. The World Health Organization states that TB-infected mothers are 'associated with a six-fold increase in perinatal deaths.' There is a large TB infection pool and together with risk factors for global ageing, slow and insufficient case detection, low cure rates and drug resistance, favors the slow incidence decline..

“世卫组织指出，感染结核病的母亲‘与围产期死亡率增加六倍有关’。结核病感染群体庞大，加之全球老龄化、病例发现缓慢且不充分、治愈率低以及药物耐药性等风险因素，导致发病率下降缓慢。”

Moreover, political conflicts significantly slow down the decline of TB burden. Tuberculosis impacts superpower politics, north-south relations, and wildlife. An increase in tuberculosis will challenge individual country leaderships, could tear the countries apart with the concomitant problems for the global economy.

此外，政治冲突显著减缓结核病负担的下降。结核病影响超级大国政治、南北关系和野生动物。结核病的增加将挑战各国领导力，可能伴随着对全球经济产生问题而使国家四分五裂。

Finally, TB is a direct threat to wildlife throughout the world. This is especially true of our closest animal relatives who are increasingly exposed to eco-tourists. They share the same vulnerabilities to TB as human beings. .

最后，结核病对全世界的野生动物构成了直接威胁。对于与人类关系最密切的动物来说尤其如此，它们越来越多地暴露在生态旅游者面前。它们与人类一样容易感染结核病。

Media Contact:

媒体联系人：

Sachin Marulkar

萨钦·马鲁卡尔

，

smarulkar@akageramed.com

斯马鲁尔卡尔@阿卡格拉梅德.康姆

SOURCE Akagera Medicines Inc

来源：阿卡盖拉医药公司

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