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




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

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.

“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.”

For more information on Revelation, please visit www.RevBiosciences.com.

About 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.

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.

About Revelation Biosciences Inc.

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.

For more information on Revelation, please visit www.RevBiosciences.com.

Forward-Looking Statements

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.

Company Contacts

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

and

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