Revelation Biosciences Inc. Announces Enrollment and Dosing Complete for Phase 2b Viral Challenge Study to Assess Efficacy of Intranasal REVTx‑99 for the Prevention of H3N2 Influenza Infection
-Primary endpoint analysis expected early Q2 2022-
-Final data expected Q2 2022-
San Diego, CA – March 15, 2022 – 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, announced today that it has completed enrollment and dosing in Phase 2b viral challenge study (RVL-VRL01) to evaluate the efficacy of intranasal REVTx-99 for the preventive treatment of H3N2 influenza (influenza A) infection in healthy humans.
REVTx-99 activates a nonspecific immune response (innate) which differentiates it from most current treatments focused on a specific immune response (adaptive) potentially allowing for broader use in most infectious viruses. The viral challenge study is the next necessary step in clinical development of REVTx-99 for the treatment of respiratory viral infections. Future development plans include clinical studies in SARS-CoV-2 and its variants, along with other respiratory viruses.
“We are grateful to the individuals volunteering to participate in this and other clinical trials, as they are essential in the development of new treatment options to help prevent and treat respiratory viral infections,” said James Rolke, Chief Executive Officer of Revelation. “The results of this study will be an important step in the development of REVTx-99, and we expect to report primary endpoint data for this study early in the second quarter of this year.”
The Phase 2b, randomized, double-blind, placebo-controlled study was conducted in Belgium and enrolled healthy individuals 18 to 55 years of age. The primary endpoint is to evaluate the efficacy of REVTx-99 in reducing area under the curve (AUC) influenza viral load in the upper airways during infection as measured by RT-qPCR. Key secondary endpoints include: AUC of total symptom score, duration of symptoms, peak symptom score, peak viral load, duration of influenza virus presence, incidence of mild to moderate influenza disease (MMID) and incidence of seroconversion.
For more information on the design of the clinical study or Revelation, please visit www.RevBiosciences.com.
About REVTx-99
REVTx-99 is a proprietary intranasal formulation in development for the prevention or treatment of respiratory viral infection and is broadly applicable to most infectious viruses including influenza A, influenza B, parainfluenza, rhinovirus, respiratory syncytial virus (RSV), SARS-CoV-2, and its variants. The active ingredient in REVTx-99 stimulates the nasal (mucosal) innate immune system via interaction with toll-like receptor 4 (TLR4) to produce protective cytokines including interferons and interferon-related proteins. These protective cytokines work in concert to blunt the ability of an invading virus to proliferate and survive. Phase 1 data showed REVTx-99 to be well-tolerated and to significantly increase intranasal protective cytokines. In addition, REVTx-99 has been assessed for prophylactic anti-viral activity in vitro against SARS-CoV-2 Delta infection in three separate cell lines, each expressing sufficient levels of ACEII and TLR4, receptors required to sufficiently demonstrate viral infection as well as REVTx-99 activity, respectively. In these in vitro studies, REVTx-99 resulted in a significant decrease in viral load with prophylactic treatment.
In addition to viral infection, REVTx-99 is also being developed for management of allergic rhinitis symptoms and chronic nasal congestion without polyps. REVTx-99 upregulates a protein which competes for the native eotaxin receptor, CCR3, preventing eotaxin from recruiting eosinophils, thereby reducing recruitment of Th2 cells, and attenuating the allergic response.
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 several product candidates in development. REVTx‑99, the lead therapeutic candidate, is an intranasal immunomodulator to prevent or treat infections caused by various respiratory viruses such as SARS-CoV-2, including its variants, influenza A and B, parainfluenza, rhinovirus, and RSV. REVTx-99 is also being developed for other indications such as: allergic rhinitis and chronic nasal congestion. REVTx‑200 is an intranasal immunomodulator adjunct to be used in combination with an intramuscular vaccination for more complete immunity. REVTx‑200 is based on the same technology used in REVTx-99. In addition to Revelation’s therapeutic pipeline, Revelation is also developing 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.
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 complete planned clinical studies of REVTx‑99; risks relating to the successful completion of RVL-CLR01 and RVL-VRL01 clinical studies; 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 REVTx‑99 and expanded indications, REVTx‑200, REVDx‑501, or any other 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; 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
Media contact:
Kristin Faulder