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Study Results From Phase 1 Studies With Exidavnemab Published in The Journal of Clinical Pharmacology

Study Results From Phase 1 Studies With Exidavnemab Published in The Journal of Clinical Pharmacology

关于Exidavnemab的一期研究结果已在《临床药理学杂志》上发表
PR Newswire ·  08/27 02:27

STOCKHOLM, Aug. 27, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the results from two phase-1 studies with exidavnemab have been published in The Journal of Clinical Pharmacology. Exidavnemab is a drug candidate under development aimed at treating diseases such as Parkinson's disease. It is a monoclonal antibody designed to target aggregated forms of the protein α-synuclein, while sparing the physiological form of the protein.

STOCKHOLm,2024年8月27日/ PRNewswire /极地生物学(BioArctic Ab)(Nasdaq Stockholm:BIOA B)今天宣布,使用exidavnemab进行的两项一期研究结果已发表在《临床药理学期刊》上。 Exidavnemab是一种正在开发中的药物候选品,旨在治疗帕金森病等疾病。这是一种单克隆抗体,专门针对蛋白质α-突触核蛋白的聚集形式,而保留了其生理形式。

In two separate phase 1 clinical studies conducted in collaboration with AbbVie, exidavnemab was tested on healthy volunteers to assess the safety, tolerability and pharmacokinetics of the candidate drug. The studies included 98 participants from different ethnic backgrounds, of which 85 received exidavnemab, either as an intravenous dose ranging from 100 to 6000 mg or a subcutaneous dose of 300 mg.

在与艾伯维(AbbVie)合作进行的两项独立的一期临床研究中,通过对健康志愿者进行测试来评估候选药物exidavnemab的安全性,耐受性和药代动力学。这些研究包括了来自不同民族背景的98名参与者,其中85人接受了exidavnemab,剂量范围从100至6000mg不等,或者皮下注射300mg。

The results showed that exidavnemab was generally well-tolerated. with an excellent half-life of approximately 30 days. This together with the high affinity and selectivity toward the pathological aggregated forms of α-synuclein is key to maintain a high target binding in the brain.

结果显示,exidavnemab耐受性良好,半衰期约为30天。这与其高亲和力和对病理性α-突触核蛋白聚集体选择性的结合,是保持大脑中高靶点结合的关键。

"Data from these two studies support the continued clinical development of exidavnemab, and we are looking forward to starting the phase 2a study later this year," said Gunilla Osswald, CEO of BioArctic, in a comment.

“这两项研究的数据支持exidavnemab的持续临床开发,并且我们期待今年晚些时候开始进行2a期研究,”极地生物学(BioArctic)首席执行官Gunilla Osswald在一份评论中表示。

The published article can be read in full here:

完整的发布文章可在此处阅读:

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

本文讨论了正在研发的药物的调查用途,不旨在传达有关功效或安全性的结论。无法保证此类调查试剂将成功完成临床开发或获得卫生主管部门的批准。

The information was released for public disclosure, through the agency of the contact person below, on August 27, 2024, at 08:00 a.m. CET.

该信息于2024年8月27日上午08:00通过下方的联系人发布以公开披露。

For further information, please contact:
Oskar Bosson, Vice President Communications and Investor Relations
E-mail: [email protected]
Phone: +46 70 410 71 80
Jiang Millington, Corporate Communication and Social Media Director
E-mail: [email protected]
Phone: +46 79 33 99 166

如需更多信息,请联系:
奥斯卡·博森,副总裁,通信和投资者关系
电子邮件:[email protected]
电话:+46 70 410 71 80
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电话:+46 79 33 99 166

About Exidavnemab

关于Exidavnemab

Exidavnemab is a monoclonal antibody drug candidate that is designed to selectively bind and eliminate aggregated forms of alpha-synuclein such as oligomers and protofibrils and fibrillar forms, which participates in neurodegenerative disorders including Parkinson's disease. The goal is to develop a disease modifying treatment that stops or slow down the progression of Parkinson's disease.

Exidavnemab是一种单克隆抗体药物候选,旨在选择性结合并消除α-突触核蛋白的聚集形式,如寡聚体、原纤维体和纤维形态,参与神经退行性疾病,包括帕金森病。目标是开发一种能够停止或减缓帕金森病进展的疾病修饰治疗方法。

About BioArctic AB

BioArctic AB大二季度报告2024年4月至6月将在中欧时间8月29日上午9:30举行,特此邀请。

BioArctic AB (publ) is a Swedish research-based biopharma company focusing on disease-modifying treatments for neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease and ALS. BioArctic focuses on innovative treatments in areas with high unmet medical needs. The company was founded in 2003 based on innovative research from Uppsala University, Sweden. Collaborations with universities are of great importance to the company together with its strategically important global partner Eisai in Alzheimer disease. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market and out-licensing potential. BioArctic's Class B share is listed on Nasdaq Stockholm Large Cap (ticker: BIOA B). For more information about BioArctic, please visit .

BioArctic AB是一家瑞典的以疾病改善为重点的生物药物公司,专注于神经退行性疾病(如阿尔茨海默病、帕金森病和ALS)的治疗。BioArctic专注于需求量大、尚未满足的领域创新治疗。该公司成立于2003年,基于瑞典乌普萨拉大学的创新研究。与大学的合作对于公司非常重要,与重要的全球合作伙伴艾伯维公司在老年痴呆症领域也具有战略重要性。项目组合是由与全球制药公司合作的全资项目和具有重要市场和许可潜力的独立项目的组合。BioArctic的B类股票在纳斯达克斯德哥尔摩大盘上市(股票代码:BIOA B)。有关BioArctic的更多信息,请访问。

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The following files are available for download:

以下文件可供下载:

Study results from phase 1 studies with exidavnemab published in The Journal of Clinical Pharmacology

exidavnemab的1期研究结果发表在《临床药理学杂志》上

SOURCE BioArctic

消息来源BioArctic

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