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Revelation Biosciences Inc. Completes Database Lock for its Phase 1b CLEAR Clinical Study of REVTx-99b for the Treatment of Allergic Rhinitis

Revelation Biosciences Inc. Completes Database Lock for its Phase 1b CLEAR Clinical Study of REVTx-99b for the Treatment of Allergic Rhinitis

启迪生物科学公司完成其1b期数据库锁定REVTx-99b治疗变应性鼻炎的明确临床研究
GlobeNewswire ·  2022/07/14 09:05

-Topline Data expected in the last week of July-

-预计7月最后一周的TOPLINE数据-

SAN DIEGO, July 14, 2022 (GLOBE NEWSWIRE) -- Revelation Biosciences Inc. (NASDAQ: REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company that is focused on the development of immunologic‑based therapies for the prevention and treatment of disease, today announced data base lock for its Phase 1b CLEAR clinical study to evaluate the effect of intranasal REVTx-99b on nasal challenge allergen in participants with allergic rhinitis to rye grass pollen. Topline data is expected in the last week of July 2022.

圣迭戈,2022年7月14日(环球网)--专注于开发基于免疫学的预防和治疗疾病疗法的临床阶段生命科学公司Revation Biosciences Inc.(纳斯达克:REVB)(以下简称“公司”或“REVATION”)今天宣布,其1b期Clear临床研究的数据库锁定,以评估鼻腔内注射REVTx-99b对对黑麦草花粉过敏的变应性鼻炎参与者的鼻挑战变应原的影响。预计2022年7月的最后一周将公布背线数据。

The Phase 1b, randomized, double-blind, placebo-controlled, crossover study design was conducted in Australia. The primary endpoint is to evaluate the effects of REVTx-99b versus placebo on safety and tolerability. Key exploratory endpoints include allergy symptoms (Total Nasal Symptom Score) and peak nasal inspiratory flow elicited by nasal allergen challenge. The study enrolled two cohorts: one cohort received study drug prior to nasal allergen challenge (the prophylactic cohort) and the second cohort received study drug after the nasal allergen challenge (the treatment cohort).

1b期随机、双盲、安慰剂对照、交叉研究设计在澳大利亚进行。主要终点是评估REVTx-99b与安慰剂对安全性和耐受性的影响。关键的研究终点包括过敏症状(鼻部症状总评分)和鼻腔变应原激发的鼻腔吸气峰值流量。这项研究招募了两个队列:一个队列在鼻变应原攻击之前接受研究药物(预防性队列),第二个队列在鼻变应原攻击后接受研究药物(治疗队列)。

Allergic rhinitis, or hay fever, is an allergic reaction to tiny particles in the air called allergens. It is a common disorder that affects millions of patients annually and significantly impacts quality of life. Symptoms include sneezing, nasal congestion, and irritation of the nose, throat, mouth, and eyes. Allergic rhinitis can lead to complications in some cases including nasal polyps, sinusitis, and middle ear infections. People with severe chronic nasal congestion sometimes require surgery. While multiple treatment options are available, many of these still have limited efficacy in preventing symptoms, and may be associated with unwanted side-effects, thus better therapies are still needed.

过敏性鼻炎,或花粉热,是对空气中称为过敏原的微小颗粒的过敏反应。这是一种常见的疾病,每年影响数百万患者,并显著影响生活质量。症状包括打喷嚏、鼻塞以及鼻、喉、口和眼睛的刺激性。过敏性鼻炎在某些情况下会导致并发症,包括鼻息肉、鼻窦炎和中耳感染。患有严重慢性鼻塞的人有时需要手术。虽然有多种治疗方案可供选择,但其中许多在预防症状方面的效果仍然有限,并可能与不想要的副作用有关,因此仍需要更好的治疗方法。

"We are delighted to have the database lock completed in a timely and efficient manner and look forward to reporting the results soon," said James Rolke, Chief Executive Officer of Revelation. "This is an important milestone taking us one step further in the development of a treatment for patients who suffer from allergic rhinitis – including patients with severe cases that may require invasive sinus surgery."

“我们很高兴及时高效地完成了数据库锁定,并期待着很快报告结果,”启迪公司首席执行官詹姆斯·罗尔克说。这是一个重要的里程碑,使我们在开发治疗过敏性鼻炎患者方面又向前迈进了一步--包括可能需要侵入性鼻窦手术的重症患者。“

For more information on Revelation, please visit .

有关《启示录》的更多信息,请访问。

About REVTx-99b

关于REVTx-99b

REVTx-99b is a proprietary intranasal formulation in development for management of allergic rhinitis symptoms including chronic nasal congestion. The active ingredient has been shown in a Phase 1 clinical study to upregulate a protein, which competes for the native eotaxin receptor, CCR3, preventing eotaxin from recruiting eosinophils and basophils, thereby reducing recruitment of Th2 cells, and attenuating the allergic response.

REVTx-99b是一种专有的鼻腔制剂,正在开发中,用于治疗包括慢性鼻塞在内的过敏性鼻炎症状。该活性成分已在一期临床研究中被证明可以上调一种蛋白质,该蛋白质与天然的嗜酸性粒细胞受体CCR3竞争,阻止嗜酸性粒细胞和嗜碱性粒细胞招募,从而减少Th2细胞的招募,并减轻过敏反应。

About Revelation Biosciences Inc.

关于启迪生物科学公司。

Revelation Biosciences, Inc. is a clinical-stage life sciences company focused on the development of immunologic-based therapies for the prevention and treatment of disease. Revelation has multiple product candidates in development. REVTx-99b, the lead therapeutic candidate, is being developed for allergic rhinitis, and is currently being evaluated as a treatment for allergic rhinitis in a Phase 1b CLEAR study. Topline results are expected in the third quarter of 2022. REVDx-501, a rapid home use diagnostic that can be used to detect any respiratory viral infection, regardless of virus type or strain, without the need for specialized instrumentation. Revelation has engaged MedWorld Advisors to facilitate partnering of the REVDx-501 asset. REVTx-200 is an intranasal immunomodulator adjunct to be used in combination with a traditional intramuscular vaccination for more complete immunity.

启迪生物科学公司是一家临床阶段的生命科学公司,专注于开发基于免疫学的预防和治疗疾病的疗法。启示录有多个候选产品正在开发中。REVTx-99b是治疗过敏性鼻炎的主要候选药物,正在开发中,目前正在1b期Clear研究中作为治疗过敏性鼻炎的药物进行评估。预计2022年第三季度将公布TOPLINE结果。REVDx-501,一种家庭使用的快速诊断,可用于检测任何呼吸道病毒感染,无论病毒类型或毒株,而不需要专门的仪器。启示录已聘请MedWorld Advisors促进REVDx-501资产的合作。REVTx-200是一种鼻腔免疫调节剂附件,可与传统的肌肉注射疫苗结合使用,以获得更完全的免疫。

For more information on Revelation, please visit .

有关《启示录》的更多信息,请访问。

Forward-Looking Statements

前瞻性陈述

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions. We caution investors that forward-looking statements are based on management's expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation's product candidates; the clinical utility of an increase in intranasal cytokine levels as a biomarker of viral infections; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the potential impact that COVID-19 may have on Revelation's suppliers, vendors, regulatory agencies, employees and the global economy as a whole; the ability of Revelation to maintain the listing of its securities on NASDAQ; investor sentiment relating to SPAC related going public transactions; the expected duration over which Revelation's balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.

本新闻稿包含修订后的《1995年私人证券诉讼改革法》中所界定的前瞻性陈述。前瞻性陈述是指非历史事实的陈述。这些前瞻性陈述一般由“预期”、“相信”、“预期”、“估计”、“计划”、“展望”和“项目”等类似表述来识别。我们提醒投资者,前瞻性陈述是基于管理层的预期,仅是对当前预期的预测或陈述,涉及已知和未知的风险、不确定性和其他因素,可能导致实际结果与前瞻性陈述预期的结果大不相同。启示录告诫读者不要过度依赖任何此类前瞻性声明,这些声明仅反映了声明发表之日。除其他因素外,以下因素可能导致实际结果与这些前瞻性陈述中描述的结果大不相同:由于竞争等原因,启示会有能力实现其财务和战略目标;启示录有能力增长和管理增长盈利能力并留住其关键员工;启示录可能会受到其他经济、业务的不利影响, 和/或竞争因素;与Revation候选产品成功开发相关的风险;作为病毒感染生物标志物的鼻腔细胞因子水平增加的临床效用;成功完成其候选产品计划的临床研究的能力;我们可能未完全登记我们的临床研究或登记所需的时间比预期更长的风险;与发生不良安全事件和/或临床研究数据或分析可能引起的意外担忧相关的风险;适用法律或法规的变化;临床研究的预期启动、临床数据的时间;临床数据的结果,包括此类研究的结果是否为阳性或是否可复制;收集的数据的结果,包括此类数据的结果和/或相关性是否可复制;我们其他临床研究的时间、成本、行为和结果;FDA、EMA或其他监管机构对未来临床数据的预期处理,包括这些数据是否足以获得批准;其候选产品未来开发活动的成功;可能开发候选产品的潜在适应症;新冠肺炎可能对启迪的供应商、供应商、监管机构、员工和全球经济产生的潜在影响;启迪维持其证券在纳斯达克上市的能力;与SPAC相关的上市交易的投资者情绪;启迪余额将为其运营提供资金的预期持续时间;以及本文所述的其他风险和不确定性,以及启迪在提交给美国证券交易委员会的其他报告和其他公开文件中不时讨论的那些风险和不确定性。

Company Contacts

公司联系人

Sandra Vedrick
Vice President, Investor Relations & Human Resources
Revelation Biosciences Inc.
Email: svedrick@revbiosciences.com

桑德拉·韦德里克
总裁副经理,投资者关系和人力资源部
启示录生物科学公司。
电子邮件:svedrick@revbiosciences.com

and

Chester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.com

切斯特·齐格蒙特,III
首席财务官
启示录生物科学公司。
电子邮件:czygmont@revbiosciences.com


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