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.
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.
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).
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.
“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.”
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, 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.
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 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.
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 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
