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Revelation Biosciences Inc. Announces Primary Endpoint Analysis for Phase 2b Viral Challenge Study to Assess Efficacy of Intranasal REVTx-99a for the Prevention of H3N2 Influenza Infection

Revelation Biosciences Inc. Announces Primary Endpoint Analysis for Phase 2b Viral Challenge Study to Assess Efficacy of Intranasal REVTx-99a for the Prevention of H3N2 Influenza Infection

启迪生物科学公司宣布2b期病毒挑战研究的主要终点分析,以评估鼻腔注射REVTx-99a预防H3N2流感感染的有效性
GlobeNewswire ·  2022/03/30 09:19

SAN DIEGO, March 30, 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, announces results from interim statistical analysis for its Phase 2b viral challenge study (RVL-VRL01) to evaluate the efficacy of intranasal REVTx-99a for the preventive treatment of H3N2 influenza (influenza A) in healthy humans. The study was conducted in Belgium and enrolled 30 healthy individuals 18 to 55 years of age who were quarantined for 14 days while participating in the study. An independent, unblinded subject matter expert panel reviewed the interim results. Based on analysis of the 30 patients through day 11 (day of discharge from the clinical unit), there were no serious adverse events reported or discontinuations due to study drug, and all subjects completed the treatment period per protocol. Efficacy data demonstrated that REVTx-99a did not meet its primary endpoint, area under the curve (AUC) of viral load by quantitative RT-PCR from nasopharyngeal swabs, and the preliminary results suggest the difference between REVTx-99a and placebo was not statistically significant.

圣迭戈,2022年3月30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--启迪生物科学公司(纳斯达克:REVB)宣布其2b期病毒挑战研究(RVL-VRL01)的中期统计分析结果,以评估鼻腔注射REVTx-99a预防健康人类H3N2型流感(甲型流感)的疗效。这项研究是在比利时进行的,招募了30名年龄在18岁至55岁之间的健康人,他们在参与研究时被隔离了14天。一个独立的、非盲目的专题专家小组审查了中期结果。根据对30名患者的分析,直到第11天(出院日),没有报告严重的不良事件或因研究药物而停药,所有受试者都按方案完成了治疗期。疗效数据显示,REVTx-99a没有达到其鼻咽拭子定量RT-PCR病毒载量曲线下面积(AUC)的主要终点,初步结果表明REVTx-99a与安慰剂的差异没有统计学意义。

"While we are disappointed in the outcome of this study, I would like to thank the study participants, the Revelation team, and the clinical research organization for conducting a well-executed study," said James Rolke, Chief Executive Officer of Revelation. "We remain committed to the development of our other product candidates including REVTx-99b for management of allergic rhinitis and other underlying conditions; and REVDx-501, our universal at home screening test for respiratory viral infection."

“虽然我们对这项研究的结果感到失望,但我要感谢研究参与者、启迪团队和临床研究机构进行了一项执行良好的研究,”启迪公司首席执行官詹姆斯·罗克说。我们继续致力于开发我们的其他候选产品,包括用于治疗过敏性鼻炎和其他潜在疾病的REVTx-99b,以及我们针对呼吸道病毒感染的通用家庭筛查测试REVDx-501。“

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, IP10, which competes for the native eotaxin receptor, CCR3, preventing eotaxin from recruiting eosinophils, 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。这种活性成分已经在一期临床研究中被证明可以上调一种名为IP10的蛋白质,该蛋白质与天然的Eoaxin受体CCR3竞争,阻止Eoaxin招募嗜酸性粒细胞,从而减少Th2细胞的招募,并减轻过敏反应。

Revelation is currently in a Phase 1b, randomized, double-blind, placebo-controlled, crossover design study. The primary endpoint is to evaluate the effects of REVTx-99b versus placebo on safety and tolerability. Key secondary endpoints include allergy symptoms (Total Nasal Symptom Score) and peak nasal inspiratory flow elicited by nasal allergen challenge. The company expects the topline data in second half 2022.

启示录目前处于1b期随机、双盲、安慰剂对照、交叉设计研究。主要终点是评估REVTx-99b与安慰剂对安全性和耐受性的影响。关键的次要终点包括过敏症状(鼻部症状总评分)和鼻腔变应原激发的鼻腔吸气峰值流量。该公司预计2022年下半年将公布背线数据。

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 chronic nasal congestion. 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. REVTx-200 is an intranasal immunomodulator adjunct to be used in combination with an 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是治疗过敏性鼻炎和慢性鼻塞的主要候选药物。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。REVTx-200是一种鼻腔免疫调节剂辅助剂,可与肌肉接种结合使用,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 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;与成功开发启迪候选产品相关的风险;作为病毒感染生物标志物的鼻内细胞因子水平增加的临床效用;成功完成其候选产品的计划临床研究的能力;我们可能无法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
投资者关系和人力资源部副总裁
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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