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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

Exidavnemab的一期研究結果已發表在《臨床藥理學雜誌》上。
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 /極地生物學(BioArctic Ab)(Nasdaq Stockholm:BIOA B)今天宣佈,使用exidavnemab進行的兩項一期研究結果已發表在《臨床藥理學期刊》上。 Exidavnemab是一種正在開發中的藥物候選品,旨在治療帕金森病等疾病。這是一種單克隆抗體,專門針對蛋白質α-突觸核蛋白的聚集形式,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.

在與艾伯維(AbbVie)合作進行的兩項獨立的一期臨床研究中,通過對健康志願者進行測試來評估候選藥物exidavnemab的安全性,耐受性和藥代動力學。這些研究包括了來自不同民族背景的98名參與者,其中85人接受了exidavnemab,劑量範圍從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.

結果顯示,exidavnemab耐受性良好,半衰期約爲30天。這與其高親和力和對病理性α-突觸核蛋白聚集體選擇性的結合,是保持大腦中高靶點結合的關鍵。

"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.

「這兩項研究的數據支持exidavnemab的持續臨床開發,並且我們期待今年晚些時候開始進行2a期研究,」極地生物學(BioArctic)首席執行官Gunilla Osswald在一份評論中表示。

The published article can be read in full here:

完整的發佈文章可在此處閱讀:

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.

本文討論了正在研發的藥物的調查用途,不旨在傳達有關功效或安全性的結論。無法保證此類調查試劑將成功完成臨床開發或獲得衛生主管部門的批准。

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.

該信息於2024年8月27日上午08:00通過下方的聯繫人發佈以公開披露。

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,請聯繫:
奧斯卡·博森,副總裁,通信和投資者關係
電子郵件:[email protected]
電話:+46 70 410 71 80
姜·米林頓,企業溝通和社交媒體董事
電郵:[email protected]
電話:+46 79 33 99 166

About Exidavnemab

關於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是一種單克隆抗體藥物候選,旨在選擇性結合並消除α-突觸核蛋白的聚集形式,如寡聚體、原纖維體和纖維形態,參與神經退行性疾病,包括帕金森病。目標是開發一種能夠停止或減緩帕金森病進展的疾病修飾治療方法。

About BioArctic AB

BioArctic AB大二季度報告2024年4月至6月將在中歐時間8月29日上午9:30舉行,特此邀請。

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爲重點的生物藥物公司,專注於神經退行性疾病(如阿爾茨海默病、帕金森病和ALS)的治療。BioArctic專注於需求量大、尚未滿足的領域創新治療。該公司成立於2003年,基於瑞典烏普薩拉大學的創新研究。與大學的合作對於公司非常重要,與重要的全球合作伙伴艾伯維公司在老年癡呆症領域也具有戰略重要性。項目組合是由與全球製藥公司合作的全資項目和具有重要市場和許可潛力的獨立項目的組合。BioArctic的B類股票在納斯達克斯德哥爾摩大盤上市(股票代碼:BIOA B)。有關BioArctic的更多信息,請訪問。

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The following files are available for download:

以下文件可供下載:

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

exidavnemab的1期研究結果發表在《臨床藥理學雜誌》上

SOURCE BioArctic

消息來源BioArctic

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