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Biora Therapeutics to Present Clinical Data on Device Function of the NaviCap Oral Delivery Platform at Digestive Disease Week 2024

Biora Therapeutics to Present Clinical Data on Device Function of the NaviCap Oral Delivery Platform at Digestive Disease Week 2024

Biora Therapeutics 將在 2024 年消化系統疾病週上發佈有關 NaviCap 口服給藥平台設備功能的臨床數據
GlobeNewswire ·  05/06 20:00

SAN DIEGO, May 06, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced that it will present clinical data on device function of the NaviCap Targeted Oral Delivery Platform at Digestive Disease Week (DDW), which will take place both virtually and in-person May 18-21, 2024 in Washington, DC.

聖地亞哥,2024年5月6日(GLOBE NEWSWIRE)——正在重新構想治療交付的生物技術公司Biora Therapeutics, Inc.(納斯達克股票代碼:BIOR)今天宣佈,將在消化疾病週上公佈有關NaviCap靶向口服給藥平台設備功能的臨床數據 (DDW),該活動將於 2024 年 5 月 18 日至 21 日在華盛頓特區以虛擬方式和麪對面形式舉行。

Details of the presentations are as follows:

演講詳情如下:

Abstract Title: Results of Human Device Function Studies for the NaviCap Targeted Oral Delivery Platform in Healthy Volunteers and Patients with UC
Poster No: Su1778
Session Title: IBD: Controlled Clinical Trials in Humans
Session Date & Time: May 19, 2024 from 12:30 PM to 1:30 PM Eastern time
Presenting Author: Shaoying Nikki Lee, PhD, Director, Clinical and Translational Science, Biora Therapeutics, Inc.
摘要標題: 針對健康志願者和UC患者的 NaviCap 靶向口服給藥平台的人體設備功能研究結果
海報編號: Su1778
會議標題: IBD:人體對照臨床試驗
會話日期和時間: 2024 年 5 月 19 日美國東部時間下午 12:30 至下午 1:30
主講作者: Shaoying Nikki Lee,博士,Biora Therapeutics, Inc. 臨床和轉化科學總監

Abstracts selected by the American Gastroenterological Association (AGA) for presentation at DDW will be available in a supplement to Gastroenterology. All information presented at DDW, including poster presentations, is embargoed until 12:01 AM Eastern on the day of the presentation. The poster presentation will be made available on the Biora Therapeutics website following the meeting.

美國胃腸病學協會(AGA)精選的在DDW上發表的摘要將作爲補編提供 胃腸病學。在DDW上展示的所有信息,包括海報演示,在發佈會當天美國東部時間凌晨 12:01 之前禁運。會議結束後,海報展示將在Biora Therapeutics網站上公佈。

About Digestive Disease Week
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 18-21, 2024. The meeting showcases more than 4,400 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at .

關於消化系統疾病周
消化系統疾病周 (DDW) 是胃腸病學、肝病學、內窺鏡檢查和胃腸道外科領域最大的醫生、研究人員和學者國際聚會。DDW由美國肝臟疾病研究協會(AASLD)、美國胃腸病學會(AGA)、美國胃腸道內窺鏡學會(ASGE)和消化道外科學會(SSAT)共同贊助,是一次面對面的在線會議,將於2024年5月18日至21日舉行。會議展示了有關胃腸道研究、醫學和技術最新進展的4,400多份摘要和數百場講座。更多信息可以在以下網址找到。

About the NaviCap Targeted Oral Delivery Platform
Biora's NaviCap targeted oral therapeutics platform utilizes a novel approach that could improve patient outcomes by enabling delivery of therapeutics directly to the site of disease, increasing therapeutic levels in tissue while reducing systemic uptake. For the 1.8 million patients in the United States who suffer from inflammatory bowel disease (IBD), existing therapeutics offer less than ideal efficacy, likely because of the challenges with safely achieving sufficient drug levels in the affected tissues. Research has shown that direct delivery of therapeutics has the potential to improve patient outcomes in IBD.
The NaviCap platform uses an ingestible device designed for direct delivery of therapeutics to improve treatment of IBD. Once swallowed, Biora's GItrac autolocation technology enables the device to autonomously identify targeted locations in the GI tract and release a therapeutic dose of up to 500μl. Studies in healthy volunteers have demonstrated accurate localization and delivery in a fasted state and demonstrated the device's ability to function in both fasted and fed states, making it potentially the first ingestible therapeutic delivery device that does not require fasting or other food restriction for use. A device function study in participants with active UC also demonstrated successful device performance in active UC patients.

關於 NaviCap 定向口服給藥平台
Biora 的 NaviCap 靶向口服治療平台 利用一種新方法,通過將治療藥物直接輸送到疾病部位,提高組織中的治療水平,同時減少全身攝取,從而改善患者的預後。對於美國180萬患有炎症性腸病(IBD)的患者來說,現有療法的療效並不理想,這可能是因爲在受影響組織中安全地達到足夠的藥物水平存在挑戰。 研究表明 直接提供療法有可能改善IBD患者的預後。
NaviCap 平台使用可攝入的設備 專爲直接提供療法而設計 改善腸易激綜合徵的治療。一旦吞下,Biora的GitRac自動定位技術使該設備能夠自主識別胃腸道中的目標位置,並釋放高達500μl的治療劑量。對健康志願者的研究表明 在快速狀態下進行準確的定位和交付 並演示了該設備的 在禁食和進食狀態下都能發揮作用的能力,使其有可能成爲第一款不需要禁食或其他食物限制即可使用的可攝入的治療性遞送設備。還對使用主動UC的參與者進行了設備功能研究 在活躍的 UC 患者中表現出成功的設備性能

About Biora Therapeutics
Biora Therapeutics is reimagining therapeutic delivery. By creating innovative smart pills designed for targeted drug delivery to the GI tract, and systemic, needle-free delivery of biotherapeutics, the company is developing therapies to improve patients' lives.

關於 Biora Therapeu
Biora Therapeutics正在重新構想治療方式。通過開發創新的智能藥丸,專爲胃腸道靶向藥物輸送以及生物治療藥物的系統性、無針輸送而設計,該公司正在開發改善患者生活的療法。

Biora is focused on development of two therapeutics platforms: the clinical-stage NaviCap targeted oral delivery platform, which is designed to improve outcomes for patients with inflammatory bowel disease through treatment at the site of disease in the gastrointestinal tract, and the preclinical-stage BioJet systemic oral delivery platform, which is designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules.

Biora專注於開發兩個治療平台:臨床階段的NaviCap靶向口服給藥平台,旨在通過胃腸道疾病部位的治療來改善炎症性腸病患者的預後;以及臨床前階段的BioJet全身口服給藥平台,該平台旨在通過無鍼口服大分子來替代注射以更好地管理慢性病。

For more information, visit bioratherapeutics.com or follow the company on LinkedIn or Twitter.

欲了解更多信息,請訪問bioratherapeutics.com或在LinkedIn或Twitter上關注該公司。

Safe Harbor Statement or Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the progress and future expectations and goals of our research and development, preclinical, and clinical trial efforts including our BT-600 clinical trial execution and data timelines, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "forward," "believe," "design," "estimate," "predict," "potential," "plan," "target," or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, our ability to innovate in the field of therapeutics, our ability to make future filings and initiate and execute clinical trials on expected timelines or at all, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding allowed patents or intended grants to result in issued or granted patents, our expectations regarding opportunities with current or future pharmaceutical collaborators or partners, our ability to raise sufficient capital to achieve our business objectives, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC and other subsequent documents, including Quarterly Reports, that we file with the SEC.

安全港聲明或前瞻性陳述
本新聞稿包含1995年《私人證券訴訟改革法》中 “安全港” 條款所指的 “前瞻性陳述”,這些陳述存在重大風險和不確定性,並基於估計和假設。除本新聞稿中包含的歷史事實陳述外,所有陳述,包括與我們的研發、臨床前和臨床試驗工作(包括我們的 BT-600 臨床試驗執行和數據時間表)的進展和未來預期和目標有關的聲明,均爲前瞻性陳述。在某些情況下,你可以通過諸如 “可能”、“可能”、“將”、“目標”、“打算”、“應該”、“可以”、“會”、“期望”、“向前”、“相信”、“設計”、“估計”、“潛力”、“計劃”、“目標” 等術語來識別前瞻性陳述,或這些術語的否定詞以及類似的表述旨在識別前瞻性陳述。這些聲明反映了截至本新聞稿發佈之日的計劃、估計和預期。這些陳述涉及已知和未知的風險、不確定性和其他因素,這些因素可能導致我們的實際業績與本新聞稿中表達或暗示的前瞻性陳述存在重大差異。此類風險、不確定性和其他因素包括:我們在治療領域的創新能力、我們在未來提交申請以及按預期時間表啓動和執行臨床試驗的能力、我們按預期時間表獲得和維持監管部門批准或批准或批准的能力、我們研究、開發和商業化新產品的計劃、臨床前研究結果與臨床研究結果之間不可預測的關係、我們對臨床研究結果的預期允許的專利或意向授權導致專利的頒發或授予、我們對與當前或未來的製藥合作者或合作伙伴合作機會的期望、我們籌集足夠資金以實現業務目標的能力,以及我們向美國證券交易委員會提交的截至2023年12月31日年度的10-K表年度報告中 “風險因素” 和 “管理層對財務狀況和經營業績的討論和分析” 中描述的風險,以及我們向美國證券交易委員會提交的其他後續文件,包括季度報告。

Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact
Chuck Padala
Managing Director, LifeSci Advisors
IR@bioratherapeutics.com
(646) 627-8390

除非法律要求,否則Biora Therapeutics明確表示不承擔任何更新任何前瞻性陳述的義務,無論是由於新信息、未來事件還是其他原因。
投資者聯繫人
查克·帕達拉
LifeSci Advisors董事總經理
IR@bioratherapeutics.com
(646) 627-8390

Media Contact
media@bioratherapeutics.com

媒體聯繫人
media@bioratherapeutics.com


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