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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

啟迪生物科學公司宣佈2b期病毒挑戰研究的主要終點分析,以評估鼻腔注射REVTx-99a預防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.

聖迭戈,2022年3月30日(環球網)--專注於開發基於免疫學的預防和治療疾病療法的臨牀階段生命科學公司--啟迪生物科學公司(納斯達克:REVB)宣佈其2b期病毒挑戰研究(RVL-VRL01)的中期統計分析結果,以評估鼻腔注射REVTx-99a預防健康人類H3N2型流感(甲型流感)的療效。這項研究是在比利時進行的,招募了30名年齡在18歲至55歲之間的健康人,他們在參與研究時被隔離了14天。一個獨立的、非盲目的專題專家小組審查了中期結果。根據對30名患者的分析,直到第11天(出院日),沒有報告嚴重的不良事件或因研究藥物而停藥,所有受試者都按方案完成了治療期。療效數據顯示,REVTx-99a沒有達到其鼻咽拭子定量RT-PCR病毒載量曲線下面積(AUC)的主要終點,初步結果表明REVTx-99a與安慰劑的差異沒有統計學意義。

"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."

“雖然我們對這項研究的結果感到失望,但我要感謝研究參與者、啟迪團隊和臨牀研究機構進行了一項執行良好的研究,”啟迪公司首席執行官詹姆斯·羅克説。我們繼續致力於開發我們的其他候選產品,包括用於治療過敏性鼻炎和其他潛在疾病的REVTx-99b,以及我們針對呼吸道病毒感染的通用家庭篩查測試REVDx-501。“

For more information on Revelation, please visit .

有關《啟示錄》的更多信息,請訪問。

About REVTx-99b

關於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是一種專有的鼻腔製劑,正在開發中,用於治療包括慢性鼻塞在內的過敏性鼻炎症狀。這種活性成分已經在一期臨牀研究中被證明可以上調一種名為IP10的蛋白質,該蛋白質與天然的Eoaxin受體CCR3競爭,阻止Eoaxin招募嗜酸性粒細胞,從而減少Th2細胞的招募,並減輕過敏反應。

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.

啟示錄目前處於1b期隨機、雙盲、安慰劑對照、交叉設計研究。主要終點是評估REVTx-99b與安慰劑對安全性和耐受性的影響。關鍵的次要終點包括過敏症狀(鼻部症狀總評分)和鼻腔變應原激發的鼻腔吸氣峯值流量。該公司預計2022年下半年將公佈背線數據。

About Revelation Biosciences Inc.

關於啟迪生物科學公司。

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.

啟迪生物科學公司是一家臨牀階段的生命科學公司,專注於開發基於免疫學的預防和治療疾病的療法。啟示錄有多個候選產品正在開發中。REVTx-99b是治療過敏性鼻炎和慢性鼻塞的主要候選藥物。REVDx-501,一種家庭使用的快速診斷,可用於檢測任何呼吸道病毒感染,無論病毒類型或毒株,而不需要專門的儀器。REVTx-200是一種鼻腔免疫調節劑輔助劑,可與肌肉接種結合使用,以獲得更完全的免疫。

For more information on Revelation, please visit .

有關《啟示錄》的更多信息,請訪問。

Forward-Looking Statements

前瞻性陳述

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.

本新聞稿包含修訂後的《1995年私人證券訴訟改革法》中所界定的前瞻性陳述。前瞻性陳述是指非歷史事實的陳述。這些前瞻性陳述一般由“預期”、“相信”、“預期”、“估計”、“計劃”、“展望”和“項目”等類似表述來識別。我們提醒投資者,前瞻性陳述是基於管理層的預期,僅是對當前預期的預測或陳述,涉及已知和未知的風險、不確定性和其他因素,可能導致實際結果與前瞻性陳述預期的結果大不相同。啟示錄告誡讀者不要過度依賴任何此類前瞻性聲明,這些聲明僅反映了聲明發表之日。除其他因素外,以下因素可能導致實際結果與這些前瞻性陳述中描述的結果大不相同:由於競爭等原因,啟示會有能力實現其財務和戰略目標;啟示錄有能力增長和管理增長盈利能力並留住其關鍵員工;啟示錄可能會受到其他經濟、業務的不利影響, 和/或競爭因素;與成功開發啟迪候選產品相關的風險;作為病毒感染生物標誌物的鼻內細胞因子水平增加的臨牀效用;成功完成其候選產品的計劃臨牀研究的能力;我們可能無法完全登記我們的臨牀研究或登記所需的時間比預期更長的風險;與發生不良安全事件和/或臨牀研究數據或分析可能引起的意外擔憂相關的風險;適用法律或法規的變化;臨牀研究的預期啟動、臨牀數據的時間;臨牀數據的結果,包括此類研究的結果是否為陽性或是否可複製;收集的數據的結果,包括此類數據的結果和/或相關性是否可複製;我們其他臨牀研究的時間、成本、行為和結果;FDA、EMA或其他監管機構對未來臨牀數據的預期處理,包括這些數據是否足以獲得批准;其候選產品未來開發活動的成功;可能開發候選產品的潛在適應症;新冠肺炎可能對啟迪的供應商、供應商、監管機構、員工和全球經濟產生的潛在影響;啟迪維持其證券在納斯達克上市的能力;與SPAC相關的上市交易的投資者情緒;啟迪餘額將為其運營提供資金的預期持續時間;以及本文所述的其他風險和不確定性,以及啟迪在提交給美國證券交易委員會的其他報告和其他公開文件中不時討論的那些風險和不確定性。

Company Contacts

公司聯繫人

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

桑德拉·韋德里克
投資者關係和人力資源部副總裁
啟示錄生物科學公司。
電子郵件:svedrick@revbiosciences.com

and

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

切斯特·齊格蒙特,III
首席財務官
啟示錄生物科學公司。
電子郵件:czygmont@revbiosciences.com


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