MENLO PARK, Calif.--(BUSINESS WIRE)--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 has been granted approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to add a multiple dose cohort to its Phase 1 clinical study of REVTx-99 in healthy volunteers (RVL-NHV01 study). REVTx-99 is in development for the treatment and prevention of respiratory viral infection, including SARS-CoV-2 Infection (COVID-19). RVL-NHV01 is a single site, placebo-controlled, single dose, escalating dose, followed by multiple dose arm to determine the safety and tolerability of intranasal REVTx-99 in healthy adult volunteers.
The Phase 1 study single dose escalation portion of the study was completed in January 2021, in which 40 study participants were dosed with REVTx-99 (n=6) or placebo (n=2). The primary endpoints were 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.
"We are pleased to have completed enrollment of all single dose cohorts with only mild local side effects and look forward to conducting the multiple dose cohort to further enable our planned COVID-19 studies," said James Rolke, Chief Executive Officer of Revelation. “With new SARS-CoV-2 variants emerging, and the continued impact of COVID-19 on the daily lives of people around the world, we remain focused on rapidly advancing an urgently needed therapy for patients in need."
Revelation expects the multiple dose cohort enrollment of RVL-NHV01 to be completed in February 2021, followed by the announcement of topline data by the end of the first quarter of 2021. Revelation plans to initiate a Phase 1/2 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 drop formulation in development for the treatment of respiratory viral infection and is broadly applicable to most infectious viruses including SARS-CoV-2 and its variants. 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 worsened clinical outcomes. REVTx-99 acts by stimulating the innate immune system at the site of infection via an alternative pathway (TLR4) 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.
REVDx-501, a rapid point of care diagnostic product that can be used to detect any respiratory viral infection including SARS-CoV-2, influenza A, Influenza B, parainfluenza, respiratory syncytial virus, etc. The diagnostic is based on a lateral flow assay format, similar to a home pregnancy test with a simple to read visual readout that provides a result in less than 10 minutes without the need for specialized instrumentation or complicated sample collection. The commercial version of the kit is self-contained, portable, and able to be shipped anywhere. The instructions will direct users with a positive result to seek confirmatory testing and/or medical treatment.
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 or strain, 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 on-going Phase 1 program for REVTx-99, including RVL-NHV01: the ability to complete planned trials of REVTx-99; expected 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 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.