Revelation Biosciences Inc. (Revelation), a clinical stage life sciences company focused on the development of immunologic-based therapies for the prevention and treatment of disease, announced today that it received acknowledgement by the Therapeutic Goods Administration (TGA) in Australia to conduct a Phase 1 clinical study of REVTx‑99 in healthy volunteers (RVL‑HV01 study). REVTx‑99 is in development as treatment for SARS‑CoV‑2 Infection (COVID‑19). RVL‑HV01 is a single site, placebo-controlled, single dose, escalating dose study to determine the safety and tolerability of intranasal REVTx‑99 in healthy adult volunteers. The study is expected to begin enrolling participants in Q4 2020.
"We are pleased that the start of a Phase 1 clinical study of REVTx-99 has been approved in Australia," said James Rolke, Chief Executive Officer of Revelation. "Initiation of this clinical study is an important step in our quest to bring this potential treatment for COVID-19 to fruition. Our dedicated team continues to work around the clock as we aim to deliver topline data in accordance with our corporate goals."
RVL‑HV01 will enroll up to 32 participants in 4 cohorts. The primary endpoints are to determine the safety and tolerability of escalating intranasal doses of REVTx‑99 in healthy adult volunteers and to determine the pharmacodynamic effect of REVTx‑99 in healthy adult volunteers as measured by nasal and systemic cytokine levels throughout the course of treatment. There are multiple exploratory pharmacodynamic endpoints.
Revelation expects enrollment of RVL‑HV01 to begin during the fourth quarter of 2020 with topline data early in the first quarter of 2021. After completion of this study, Revelation plans to initiate a Phase 2 study during the first half of 2021 in early stage COVID‑19 patients at risk for hospitalization.
For more information on Revelation, please visit www.RevBiosciences.com.
REVTx‑99 is a proprietary intranasal formulation of phosphorylated hexaacylated disaccharide or PHAD®, a synthetic version of monophosphoryl lipid A. SARS‑CoV‑2 viral proteins have been shown to block the production of interferons, a key part of the innate immune response to viral infection, resulting in worse outcomes. REVTx‑99 acts by stimulating the innate immune response via interaction with toll-like receptor 4 (TLR4) and activation of the TIR-domain-containing adapter-inducing interferon-β (TRIF) pathway to produce protective cytokines including Type I and Type II interferons. The innate immune system is the first line of defense against invading pathogens such as bacteria and viruses. Toll-like receptors (TLRs) are associated with sentinel cells (e.g. macrophages, dendritic cells) and serve a vital role in the innate immune system response. TLRs recognize repeated molecular patterns associated with pathogens (PAMPS). When a pathogen invades a subject, TLRs recognize PAMPS as foreign and activate the innate immune response, inducing the production of numerous cytokines to combat the invading pathogen and stimulate the adaptive immune 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. The Company has several product candidates in development. REVTx‑99, the lead therapeutic candidate, is an intranasal immunomodulator for the early treatment of SARS‑CoV‑2 infection. An expansion of REVTx‑99 therapeutic indications is planned, targeting early treatment and prevention of respiratory viral infection such as influenza A or B, parainfluenza, and respiratory syncytial virus. 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 the Company’s therapeutic pipeline, Revelation is also developing REVDx‑501, a rapid point of care diagnostic that can be used to detect any respiratory viral infection regardless of virus type without the need for specialized instrumentation. For more information on Revelation, please visit www.RevBiosciences.com.
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. 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. These risks include, but are not limited to, risks relating to: the timing for the filing of an Investigational New Drug Application; the timing, costs, conduct, and outcome of RVL-HV01; 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 our product candidates may be developed; the potential impact that COVID-19 may have on us, our suppliers, vendors, regulatory agencies, our employees, and the global economy as a whole; and the expected duration over which the Company’s balance will fund us.
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Vice President, Investor Relations & Human Resources
Revelation Biosciences Inc.
Chester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.