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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

啟迪生物科學公司完成其1b期數據庫鎖定REVTx-99b治療變應性鼻炎的明確臨牀研究
GlobeNewswire ·  2022/07/14 09:05

-Topline Data expected in the last week of July-

-預計7月最後一週的TOPLINE數據-

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.

聖迭戈,2022年7月14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Revation Biosciences Inc.(納斯達克:REVB)(以下簡稱“公司”或“REVATION”)今天宣佈,其1b期Clear臨牀研究的數據庫鎖定,以評估鼻腔內注射REVTx-99b對對黑麥草花粉過敏的變應性鼻炎參與者的鼻挑戰變應原的影響。預計2022年7月的最後一週將公佈背線數據。

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期隨機、雙盲、安慰劑對照、交叉研究設計在澳大利亞進行。主要終點是評估REVTx-99b與安慰劑對安全性和耐受性的影響。關鍵的研究終點包括過敏症狀(鼻部症狀總評分)和鼻腔變應原激發的鼻腔吸氣峯值流量。這項研究招募了兩個隊列:一個隊列在鼻變應原攻擊之前接受研究藥物(預防性隊列),第二個隊列在鼻變應原攻擊後接受研究藥物(治療隊列)。

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.

過敏性鼻炎,或花粉熱,是對空氣中稱為過敏原的微小顆粒的過敏反應。這是一種常見的疾病,每年影響數百萬患者,並顯著影響生活質量。症狀包括打噴嚏、鼻塞以及鼻、喉、口和眼睛的刺激性。過敏性鼻炎在某些情況下會導致併發症,包括鼻息肉、鼻竇炎和中耳感染。患有嚴重慢性鼻塞的人有時需要手術。雖然有多種治療方案可供選擇,但其中許多在預防症狀方面的效果仍然有限,並可能與不想要的副作用有關,因此仍需要更好的治療方法。

"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."

“我們很高興及時高效地完成了數據庫鎖定,並期待着很快報告結果,”啟迪公司首席執行官詹姆斯·羅爾克説。這是一個重要的里程碑,使我們在開發治療過敏性鼻炎患者方面又向前邁進了一步--包括可能需要侵入性鼻竇手術的重症患者。“

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, 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。該活性成分已在一期臨牀研究中被證明可以上調一種蛋白質,該蛋白質與天然的嗜酸性粒細胞受體CCR3競爭,阻止嗜酸性粒細胞和嗜鹼性粒細胞招募,從而減少Th2細胞的招募,並減輕過敏反應。

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 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.

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是治療過敏性鼻炎的主要候選藥物,正在開發中,目前正在1b期Clear研究中作為治療過敏性鼻炎的藥物進行評估。預計2022年第三季度將公佈TOPLINE結果。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。啟示錄已聘請MedWorld Advisors促進REVDx-501資產的合作。REVTx-200是一種鼻腔免疫調節劑附件,可與傳統的肌肉注射疫苗結合使用,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 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Revation候選產品成功開發相關的風險;作為病毒感染生物標誌物的鼻腔細胞因子水平增加的臨牀效用;成功完成其候選產品計劃的臨牀研究的能力;我們可能未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
總裁副經理,投資者關係和人力資源部
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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