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Revelation Biosciences Inc. Receives Approval to Begin a Phase 1b Clinical Study of REVTx-99 as an Experimental Treatment for Allergic Rhinitis and Chronic Nasal Congestion
-Phase 1b study will investigate the efficacy of REVTx-99 on nasal symptoms elicited by nasal allergen challenge- -Top-line data anticipated in the first
About this update from Revelation Biosciences, Inc.
[{"type":"text","content":"-Phase 1b study will investigate the efficacy of REVTx-99 on nasal symptoms elicited by nasal allergen challenge- -Top-line data anticipated in the first quarter of 2022- SAN DIEGO, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Revelation Biosciences Inc. (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 it has been granted ethics committee approval (Bellberry Limited Human Research Ethics Committee [HREC]) in Australia to conduct a Phase 1b allergen challenge clinical study (RVL-CLR01) to evaluate the potential utility of REVTx-99 for treating patients with allergic rhinitis and patients with chronic nasal congestion. “REVTx-99 is being developed for preventing and treating respiratory viral infections, like influenza and COVID-19. However, based on our phase 1 biomarker data, we believe REVTx-99 may also prove successful in reducing allergy symptoms, including chronic nasal congestion,” said James Rolke, Chief Executive Officer of Revelation Biosciences. In the US, approximately 8% of adults and 7% of children have allergies that cause symptoms of allergic rhinitis, also called hay fever, based on current CDC data. Hay fever symptoms include itchy eyes, itchy nose, sneezing, runny nose and nasal congestion caused by seasonal, perennial, or even unknown sources of allergies. In some people the allergies can trigger long term allergen-related chronic nasal congestion (nasal congestion lasting for twelve or more weeks). Chronic nasal congestion affects approximately 12% of the US adult population, equating to at least 29 million people in the US having nasal congestion for three or more months out of the year. The Phase 1b, randomized, double-blind, placebo-controlled, crossover design study will enroll up to 28 participants. The primary endpoint is to evaluate the effects of REVTx-99 versus placebo on safety and tolerability. Key secondary endpoints include allergy symptoms and peak nasal inspiratory flow elicited by nasal allergen challenge. The study will have two cohorts, each cohort will receive an allergen challenge administered either before (prophylactic) study drug administration or after (treatment) study drug administration, then after a washout period the cohorts will crossover to either after or befor...