This Phase 2 clinical study will evaluate paridiprubart (EB05) in hospitalized patients with acute respiratory distress syndrome (ARDS) due to a variety of causes.

这项2期临床研究将评估由于各种原因导致的急性呼吸窘迫综合征（ARDS）住院患者的帕利匹鲁（EB05）。

This BARDA-funded project is expected to complement Edesa's ongoing drug development activities in COVID-19 ARDS.

该BARDA资助的项目有望补充Edesa正在进行的新型冠状病毒肺炎ARDS药物开发活动。

Paridiprubart was selected following a competitive review process of multiple host-directed therapeutic candidates.

Paridiprubart是在对多个宿主导向的治疗候选人进行竞争性审查后选择的。

TORONTO, ON / ACCESSWIRE / June 24, 2024 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics (HDTs) for immuno-inflammatory diseases, announced today that its first-in-class drug candidate has been selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S.

多伦多，ON/ACCESSWIRE/June 24，2024/Edesa Biotech，Inc.（纳斯达克：EDSA），一家临床阶段的生物制药公司，专注于开发针对免疫炎症性疾病的宿主导向疗法（HDTs），今天宣布其第一批候选药物已被美国生物医学高级研究与发展局（BARDA）选中，该局是美国战略准备和应对管理局的一部分。

Department of Health and Human Services, for evaluation in a U.S. government-funded clinical study..

美国卫生与公众服务部（Department of Health and Human Services），用于在美国政府资助的临床研究中进行评估。。

Edesa's drug paridiprubart represents a new class of HDTs that are designed to modulate the body's own immune response when confronted with known or unknown public health threats such as pandemic influenza, COVID-19, other emerging infectious diseases, and chemical, biological, radiological, and nuclear incidents.

。

Importantly, HDTs are agnostic to the causal agent and can be stockpiled preemptively to respond to public health emergencies and biodefense..

重要的是，HDT对病原体不可知，可以先发制人地储存，以应对公共卫生紧急情况和生物防御。。

'HDTs have the potential to become key countermeasures for both critical care medicine as well as pandemic preparedness and biodefense, and we are pleased to be part of public-private efforts to speed the development of novel therapeutics that are threat-agnostic and can be rapidly deployed to protect civilian and military populations,' said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech..

Edesa Biotech首席执行官Par Nijhawan医学博士说：“HDT有可能成为重症监护医学以及大流行防范和生物防御的关键对策，我们很高兴成为公私合作的一部分，以加速开发不受威胁的新型治疗方法，并可快速部署以保护平民和军人。”。。

The BARDA-funded Phase 2 platform trial will be a randomized, double-blinded, placebo-controlled, multi-center U.S. clinical trial to investigate three novel threat-agnostic host-directed therapeutics, including paridiprubart, in hospitalized adult patients with ARDS. The BARDA study of paridiprubart is expected to build on the success of a Phase 2 clinical study that the company completed during the COVID-19 pandemic which demonstrated that paridiprubart reduced mortality by 84% among critically ill ARDS patients.

BARDA资助的2期平台试验将是一项随机，双盲，安慰剂对照，多中心的美国临床试验，旨在研究住院成人ARDS患者的三种新型威胁不可知的宿主导向治疗药物，包括帕立哌特。BARDA对帕利帕特的研究预计将建立在该公司在新型冠状病毒肺炎大流行期间完成的第二阶段临床研究的成功基础上，该研究表明帕利帕特可将重症ARDS患者的死亡率降低84%。

A parallel study using an in vitro model also demonstrated that paridiprubart inhibits a key mediator of inflammatory responses from influenza and other pathogens. A separate Edesa-sponsored Phase 3 study of paridiprubart in patients with ARDS due to SARS-CoV-2 infection is currently ongoing in Canada and the U.S..

使用体外模型进行的一项平行研究还表明，帕立哌特抑制流感和其他病原体炎症反应的关键介质。目前，加拿大和美国正在进行一项由Edesa赞助的针对SARS-CoV-2感染引起的ARDS患者的帕利匹鲁巴特的3期研究。。

Dr. Nijhawan said that the data from the BARDA-run study, which includes an exploratory biomarker study, could provide additional support and insight for expanding the utility of paridiprubart. 'We expect this parallel study to inform our development, regulatory, and commercialization plans. Our ultimate goal is to label paridiprubart as a standard-of-care drug therapy for all-cause ARDS,' he said..

Nijhawan博士说，来自BARDA run研究的数据，包括一项探索性生物标志物研究，可以为扩大帕利帕特的效用提供额外的支持和见解我们期望这项平行研究为我们的开发，监管和商业化计划提供信息。他说：“我们的最终目标是将帕立哌鲁作为全因ARDS的标准治疗药物。”。。

The BARDA-funded study will be managed under a BARDA contract with PPD Development, LP, a clinical research business of Thermo Fisher Scientific, Inc. For the paridiprubart cohort of the study, patients will be randomized one-to-one to either paridiprubart plus Standard of Care (SOC) or to a placebo plus SOC control arm.

BARDA资助的研究将根据与Thermo Fisher Scientific，Inc.的临床研究业务PPD Development，LP的BARDA合同进行管理。对于该研究的paridiprubart队列，患者将被一对一随机分配到paridiprubart plus标准护理（SOC）或安慰剂加SOC对照组。

Edesa will provide drug products to the study as well as technical support. Additional details regarding this trial can be found on the BARDA website..

Edesa将为研究提供药品和技术支持。有关此试验的更多详细信息，请访问BARDA网站。。

About ARDS

Acute Respiratory Distress Syndrome manifests in some patients as an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few recommended treatments other than supplemental oxygen and mechanical ventilation, and mortality rates are high.

急性呼吸窘迫综合征在一些患者中表现为过度的免疫反应，导致肺部炎症和损伤，从而阻止肺部氧化血液并最终剥夺身体的氧气。对于中度至重度病例，除补充氧气和机械通气外，目前推荐的治疗方法很少，死亡率很高。

In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury, and other causes. Prior to the pandemic, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year..

除了病毒引起的肺炎外，ARDS还可能由烟雾/化学物质吸入，败血症，胸部受伤和其他原因引起。在大流行之前，ARDS占重症监护病房住院人数的10%，每年代表全球300多万患者。。

About Paridiprubart

关于Paridiprubart

Paridiprubart is a first-in-class human monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. This host-directed therapeutic candidate inhibits toll-like receptor 4 (TLR4), a key immune signaling receptor that has been shown to be activated both by viruses, like SARS-CoV-2, SARS-CoV-1, and influenza, as well as in the pathogenesis of chronic autoimmune diseases..

Paridiprubart是针对涉及先天免疫反应失调的急性和慢性疾病适应症开发的一流人类单克隆抗体。这种宿主导向的治疗候选物抑制toll样受体4（TLR4），这是一种关键的免疫信号受体，已被证明可被SARS-CoV-2，SARS-CoV-1和流感等病毒激活，以及慢性自身免疫性疾病的发病机制。。

About Edesa's Phase 3 Clinical Study

关于Edesa的3期临床研究

Edesa's Phase 3 study of paridiprubart is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of paridiprubart in critical-care patients. The current protocol will recruit ARDS subjects hospitalized with SARS-CoV-2 infections who are on invasive mechanical ventilation, both with and without additional organ support.

Edesa的帕利帕特3期研究是一项多中心，随机，双盲，安慰剂对照研究，旨在评估帕利帕特在重症监护患者中的疗效和安全性。目前的方案将招募住院治疗SARS-CoV-2感染的ARDS受试者，他们接受有创机械通气，无论是否有额外的器官支持。

The primary endpoint of the trial is the mortality rate at 28 days..

试验的主要终点是28天的死亡率。。

About Edesa Biotech, Inc.

。

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. The company's most advanced drug candidate is paridiprubart (EB05), a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses.

Edesa Biotech，Inc.（纳斯达克：EDSA）是一家临床阶段的生物制药公司，开发创新方法来治疗炎症和免疫相关疾病。该公司最先进的候选药物是paridiprubart（EB05），这是一种针对急性和慢性疾病适应症开发的单克隆抗体，涉及先天免疫反应失调。

Edesa is currently evaluating paridiprubart (EB05) in a Phase 3 study as a potential treatment for ARDS, a life-threatening form of respiratory failure. In addition, Edesa is developing an sPLA2 inhibitor, EB01 (daniluromer), as a topical treatment for chronic allergic contact dermatitis (ACD), a common occupational skin condition.

Edesa目前正在一项3期研究中评估帕立哌特（EB05）作为ARDS（一种危及生命的呼吸衰竭）的潜在治疗方法。此外，Edesa正在开发一种sPLA2抑制剂EB01（daniluromer），作为慢性过敏性接触性皮炎（ACD）的局部治疗，ACD是一种常见的职业性皮肤病。

The company has also received regulatory approval to conduct a Phase 2 trial of its EB06 monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. Edesa is also planning to file an investigational new drug application for a future Phase 2 study of paridiprubart (EB05) for pulmonary fibrosis.

该公司还获得监管部门的批准，将对其EB06单克隆抗体进行第二阶段试验，以治疗白癜风，白癜风是一种改变生命的自身免疫性疾病，会导致皮肤失去斑块的颜色。Edesa还计划提交一份研究性新药申请，用于未来的帕立哌特（EB05）治疗肺纤维化的2期研究。

Sign up for news alerts. Connect with us on X (Twitter) and LinkedIn..

注册新闻提醒。通过X（Twitter）和LinkedIn与我们联系。。

Edesa Forward-Looking Statements

Edesa前瞻性声明

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as 'anticipate,' 'believe,' 'plan,' 'estimate,' 'expect,' 'intend,' 'may,' 'will,' 'would,' 'could,' 'should,' 'might,' 'potential,' or 'continue' and variations or similar expressions, including statements related to: the company's belief that the BARDA study could provide additional support and insight for expanding the utility of EB05; the company's expectation that the BARDA study will inform Edesa's development, regulatory and commercialization plans; the company's goal of labeling EB05 as a standard-of-care drug therapy for all-cause ARDS; and the company's timing and plans regarding its clinical studies in general.

本新闻稿可能包含经修订的《1933年证券法》第27A节和经修订的《1934年证券交易法》第21E节所指的前瞻性声明。前瞻性陈述可以通过使用诸如“预期”，“相信”，“计划”，“估计”，“期望”，“打算”，“可能”，“意志”，“会”，“可能”，“应该”，“可能”，“潜在的”或“继续”等词语以及类似的表达来识别，包括与以下相关的陈述：公司相信BARDA研究可以为扩大EB05的效用提供额外的支持和见解；公司期望BARDA研究将为Edesa的开发、监管和商业化计划提供信息；该公司的目标是将EB05标记为全因ARDS的标准护理药物治疗；以及该公司关于其临床研究的总体时间和计划。

Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements.

读者不应过度依赖这些前瞻性陈述，因为这些陈述并不能保证未来的表现。无法保证前瞻性陈述将被证明是准确的，因为所有此类前瞻性陈述都涉及已知和未知的风险、不确定性和其他因素，这些因素可能导致实际结果或未来事件与前瞻性陈述存在重大差异。

Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreeme.

这些风险包括：Edesa获得监管部门批准或成功商业化其任何候选产品的能力，无法获得足够资金资助Edesa运营的风险，或可能无法获得对Edesa不利的商业条款，Edesa候选产品可能无法有效对抗其临床试验中测试的疾病的风险，Edesa未能遵守许可协议条款的风险。

Contact:

联系人：

Gary Koppenjan

加里·科彭詹

Edesa Biotech, Inc.

Edesa生物技术公司。

(805) 488-2800

(805) 488-2800

investors@edesabiotech.com

investors@edesabiotech.com

SOURCE: Edesa Biotech, Inc.

资料来源：Edesa Biotech，Inc。

View the original press release on accesswire.com

在accesswire.com上查看原始新闻稿