Revelation Biosciences Inc. Announces Safety Monitoring Committee Recommendation for Continuing Evaluation of REVTx-99b for the Treatment of Allergic Rhinitis
SAN DIEGO, May 23, 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 that the independent Safety Monitoring Committee (SMC) reviewed data for 14 of patients treated in the Phase 1b clinical study of REVTx-99b for the treatment of allergic rhinitis and patients with chronic nasal congestion without polyps. Based on those findings, the SMC recommended the continuation of the study without modification. The clinical study is being conducted in Australia.
“The SMC's recommendation to continue enrollment of the Phase 1b study, without modification, is an important milestone for our lead drug candidate, REVTx-99b, as a potential therapy for the millions of people who suffer from allergies that cause symptoms of allergic rhinitis, also called hay fever, which can lead to complications in some cases: nasal polyps, sinusitis, and middle ear infections,” said James Rolke, Chief Executive Officer of Revelation. “We are grateful to the patients and investigators who have participated in study, and we look forward to continuing the development of REVTx-99b”
The Phase 1b, randomized, double-blind, placebo-controlled, crossover design study is expected to complete enrollment in the third quarter of 2022. 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 study will have two cohorts: one cohort will receive study drug before the nasal allergen challenge (the prophylactic cohort) and the second cohort will receive study drug after the nasal allergen challenge (the treatment cohort).
The company expects the topline data in the third quarter of 2022.
For more information on Revelation, please visit www.RevBiosciences.com.
About Allergic Rhinitis
Allergic rhinitis also called hay fever, is a very common disorder that affects millions of patients annually and the hallmark complaint of nasal obstruction significantly impacts the quality of life. It is an allergic reaction to tiny particles in the air called allergens. Symptoms include sneezing, nasal congestion and irritation of the nose, throat, mouth and eyes. Some treatment options may include antihistamines, anti-inflammatory nasal sprays, anti-leukotrienes, and surgery. Allergic rhinitis can lead to complications in some cases: nasal polyps, sinusitis, and middle ear infections. People with severe chronic nasal congestion sometimes need surgery.
REVTx-99b is a proprietary intranasal formulation in development for management ofallergic 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, 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 third quarter of 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 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 an intramuscular vaccination for more complete immunity.
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. 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.
Chester Zygmont, III