SAN DIEGO, July 08, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today announced further details on its virtual event to be held on Wednesday, July 17, 2024. The event will feature Bruce Sands, MD, MS (Icahn School of Medicine at Mount Sinai) and Brian Feagan, MD, FRCPC (Schulich School of Medicine & Dentistry at the University of Western Ontario), who will discuss the unmet need and current treatment landscape for patients with ulcerative colitis (UC), as well as the value of colonic drug delivery for improving efficacy..

2024年7月8日，圣地亚哥（环球通讯社）--生物技术公司Biora Therapeutics，Inc.（纳斯达克：BIOR）今天宣布了将于2024年7月17日（星期三）举行的虚拟活动的进一步细节。该活动将由医学博士Bruce Sands（西奈山伊坎医学院）和医学博士Brian Feagan（西安大略大学Schulich医学与牙科学院）参加，他们将讨论溃疡性结肠炎（UC）患者未满足的需求和当前的治疗情况，以及结肠给药对提高疗效的价值。。

Biora leadership will highlight key results from the Phase 1 clinical trial of BT-600, an orally administered drug-device combination in development for the treatment of patients with ulcerative colitis (UC). BT-600 leverages Biora’s ingestible NaviCap™ device to deliver a proprietary liquid formulation of tofacitinib directly to the colon..

Biora领导层将重点介绍BT-600第一阶段临床试验的关键结果，BT-600是一种正在开发的用于治疗溃疡性结肠炎（UC）患者的口服药物-装置组合。BT-600利用Biora的可摄入NaviCap™设备将托法替尼的专有液体制剂直接输送到结肠。。

“I look forward to sharing details of our Phase 1 results, which show the NaviCap platform reliably and precisely delivers drug throughout the colon, including the sites most commonly affected in patients with UC,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics. “Delivery of therapeutics directly to affected tissues in the colon could improve patient outcomes in UC.

Biora Therapeutics首席医疗官Ariella Kelman医学博士说：“我期待着分享我们第一阶段结果的详细信息，这些结果表明，NaviCap平台可以可靠而准确地在整个结肠中输送药物，包括UC患者最常受影响的部位。”。“将治疗药物直接输送到结肠受影响的组织可以改善UC患者的预后。

This clinical trial provides proof of concept for our anatomically targeted approach to therapeutic delivery and gives us confidence to study BT-600 next in patients with UC.”.

这项临床试验为我们的解剖学靶向治疗方法提供了概念证明，并使我们有信心在UC患者中研究BT-600 next。”。

A live question and answer session will follow the formal presentations.

正式演讲后将进行现场问答。

Virtual Event Details

虚拟活动详细信息

Date:

日期：

Wednesday, July 17, 2024

2024年7月17日，星期三

Time:

时间：

2:00 PM Eastern / 11:00 AM Pacific time

2： 东部时间下午00点/太平洋时间上午11:00

Registration:

注册：

https://lifescievents.com/event/biora/

https://lifescievents.com/event/biora/

A replay will be available online following the event.

活动结束后将在线提供重播。

About Bruce Sands, MD, MS

关于Bruce Sands，MD，MS

Bruce Sands, MD, MS is the Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai, New York, NY. Dr. Sands was awarded his BA and MD from Boston University, and trained in internal medicine at the Hospital of the University of Pennsylvania. After completing GI fellowship at the Massachusetts General Hospital, he joined the faculty of Harvard Medical School and served as the Acting Chief of the Gastrointestinal Unit at MGH before moving to Mount Sinai in 2010 as Chief of the Dr.

布鲁斯·桑兹（BruceSands）医学博士（MS）是纽约西奈山伊坎医学院（MountSinai，New York，NY）的伯里尔·克罗恩（BurrillB.Crohn）博士（Dr。桑兹博士获得波士顿大学学士和医学博士学位，并在宾夕法尼亚大学医院接受内科培训。在麻省总医院完成GI奖学金后，他加入了哈佛医学院，并担任了MGH胃肠科的代理主任，然后于2010年作为Dr。

Henry D. Janowitz Division of Gastroenterology. Dr. Sands is widely recognized for his clinical investigations of new therapeutics for the inflammatory bowel diseases and has published over 250 original manuscripts. He was the lead investigator of the landmark studies ACCENT 2, UNIFI, and VARSITY, published in the New England Journal of Medicine..

Henry D.Janowitz消化内科。桑兹博士因其对炎症性肠病新疗法的临床研究而广受认可，并发表了250多篇原稿。他是《新英格兰医学杂志》上发表的里程碑式研究口音2、UNIFI和VARSITY的首席研究员。。

About Brian Feagan, MD, FRCPC

关于FRCPC医学博士Brian Feagan

Brian Feagan, MD, FRCPC is a Professor of Medicine at the Schulich School of Medicine & Dentistry at the University of Western Ontario, a gastroenterologist at London Health Sciences Centre in Ontario, Canada, and the Senior Scientific Director of Alimentiv, Inc. Dr. Feagan completed his MD at the University of Western Ontario, and his postdoctoral training included a residency in internal medicine and a clinical fellowship in gastroenterology in the Department of Medicine at UWO, and postgraduate training in the Department of Epidemiology and Biostatistics at McMaster University, Ontario.

Brian Feagan，医学博士，FRCPC是西安大略大学Schulich医学与牙科学院的医学教授，加拿大安大略省伦敦健康科学中心的胃肠病学家，Alimentiv，Inc.的高级科学总监。Feagan博士在西安大略大学完成了医学博士学位，他的博士后培训包括在UWO医学系获得内科住院医师和胃肠病临床研究金，以及在安大略省麦克马斯特大学流行病学和生物统计学系进行研究生培训。

His research is focused on the development, validation and optimization of outcome measures to assess the efficacy of novel therapeutics in Crohn’s disease (CD) and ulcerative colitis (UC), with a specific focus on the design and execution of large-scale randomized controlled trials. Dr. Feagan has been the principal investigator in over 140 multi-center randomized controlled trials in CD and UC..

他的研究重点是开发，验证和优化结果指标，以评估克罗恩病（CD）和溃疡性结肠炎（UC）新型疗法的疗效，特别关注大规模随机对照试验的设计和执行。费根博士是CD和UC 140多项多中心随机对照试验的主要研究者。。

About BT-600

关于BT-600

BT-600 is a drug/device combination of Biora’s NaviCap™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib, for the potential treatment of moderate to severe ulcerative colitis. The NaviCap device is orally administered and has been designed for anatomically targeted therapeutic delivery directly to the colon in this application..

BT-600是Biora的NaviCap™可摄入药物递送装置与专有的托法替尼液体制剂的药物/装置组合，用于潜在治疗中度至重度溃疡性结肠炎。NaviCap装置是口服给药的，并且在本应用中设计用于直接向结肠进行解剖学靶向治疗。。

About the NaviCap™ Targeted Oral Delivery Platform

关于NaviCap™靶向口服给药平台

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 activity 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 activity in the affected tissues. Research has shown that targeted delivery of therapeutics has the potential to improve patient outcomes in IBD..

Biora的NaviCap靶向口服治疗平台采用了一种新方法，可以通过将治疗剂直接输送到疾病部位来改善患者的预后，从而增加组织中的治疗活性，同时减少全身摄取。对于美国180万患有炎症性肠病（IBD）的患者，现有疗法的疗效不太理想，这可能是因为在受影响的组织中安全地获得足够的药物活性面临挑战。研究表明，靶向治疗有可能改善IBD患者的预后。。

The NaviCap platform uses an ingestible device designed for targeted delivery of therapeutics to improve treatment of ulcerative colitis. 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 of the NaviCap device in healthy volunteers and patients with ulcerative colitis demonstrated successful delivery to the colon regardless of variable GI conditions, in both fasted and fed states..

NaviCap平台使用一种可摄取的装置，该装置设计用于靶向递送治疗剂，以改善溃疡性结肠炎的治疗。一旦吞咽，Biora的GItrac™自动定位技术使该设备能够自主识别胃肠道中的目标位置，并释放高达500µl的治疗剂量。对健康志愿者和溃疡性结肠炎患者进行的NaviCap装置研究表明，无论在禁食和进食状态下，胃肠道状况如何，都能成功输送到结肠。。

About Ulcerative Colitis

关于溃疡性结肠炎

Ulcerative colitis (UC) is a type of IBD that causes chronic inflammation and damage to the colon. Common symptoms include abdominal pain, increased bowel movements, stool urgency, and rectal bleeding. Despite the availability of advanced treatments for UC, including biologics, immunomodulators, and targeted synthetic small molecules, only about 40% of patients achieve clinical remission in induction trials.

溃疡性结肠炎（UC）是一种IBD，可引起慢性炎症和结肠损伤。常见症状包括腹痛，排便增加，大便急迫和直肠出血。尽管有针对UC的先进治疗方法，包括生物制剂，免疫调节剂和靶向合成小分子，但只有约40%的患者在诱导试验中达到临床缓解。

Surgical intervention is needed in approximately 20% of UC patients, with up to 10% of patients requiring surgical removal of the colon. About 1.5 million people are affected with UC in the United States alone, and ~40,000 new cases are diagnosed each year..

大约20%的UC患者需要手术干预，多达10%的患者需要手术切除结肠。仅在美国就有约150万人患有UC，每年诊断出约40000例新病例。。

About Biora Therapeutics

关于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.

Biora Therapeutics正在重新想象治疗性分娩。通过创建创新的智能药丸，旨在将药物靶向输送到胃肠道，以及全身无针输送生物治疗药物，该公司正在开发改善患者生活的疗法。

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

Biora专注于开发两个治疗平台：NaviCap™靶向口服给药平台，旨在通过在胃肠道疾病部位进行治疗来改善炎症性肠病患者的预后；BioJet™全身口服给药平台，旨在替代注射，通过无针口服大分子来更好地管理慢性疾病。。

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

有关更多信息，请访问bioratherapeutics.com或在LinkedIn或X上关注该公司。

Safe Harbor Statement or Forward-Looking Statements

安全港声明或前瞻性声明

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 activities, and partnering and collaboration efforts with third parties, are forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》中“安全港”条款所指的“前瞻性声明”，这些声明具有重大风险和不确定性，并基于估计和假设。除本新闻稿中包含的历史事实声明外，所有声明均为前瞻性声明，包括关于我们研究和开发，临床前和临床试验活动以及与第三方合作和协作努力的进展和未来期望和目标的声明。

In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “anticipate,” “forward,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,” “target,” or the negative of these terms, and similar expressions intended to identify forward-looking statements.

在某些情况下，您可以通过诸如“可能”、“可能”、“将要”、“目标”、“打算”、“应该”、“可能”、“可以”、“会”、“期望”、“预期”、“展望”、“相信”、“设计”、“估计”、“预测”、“潜在”、“计划”、“目标”或这些术语的否定词等术语来识别前瞻性陈述，以及旨在识别前瞻性陈述的类似表达。

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.

这些声明反映了截至本新闻稿发布之日，我们的计划、估计和期望。这些声明涉及已知和未知的风险、不确定性和其他因素，这些因素可能导致我们的实际结果与本新闻稿中明示或暗示的前瞻性声明存在重大差异。

Such risks, uncertainties, and other factors include, among others, our ability to innovate in the field of therapeutics, our ability to make future FDA 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 clini.

这些风险、不确定性和其他因素包括，除其他因素外，我们在治疗领域的创新能力，我们在预期时间表上或根本上提交未来FDA文件并启动和执行临床试验的能力，我们在预期时间表上或根本上获得和维持监管部门批准或批准我们产品的能力，我们研究、开发和商业化新产品的计划，临床前研究结果与clini之间不可预测的关系。

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.

Biora Therapeutics明确否认因新信息、未来事件或其他原因而更新任何前瞻性声明的义务，除非法律要求。

Investor Contact

投资者联系人

Chuck Padala

Chuck Padala

Managing Director, LifeSci Advisors

LifeSci Advisors常务董事

IR@bioratherapeutics.com

IR@bioratherapeutics.com

(646) 627-8390

(646) 627-8390

Media Contact

媒体联系人

Liz Robinson

利兹·罗宾逊

CG Life

CG寿命

lrobinson@cglife.com

lrobinson@cglife.com