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Revelation Biosciences Inc. Announces Initiation of a Phase 1b Clinical Study of REVTx-99 for the Experimental Treatment of Allergic Rhinitis and Chronic Nasal Congestion
-Top-line data anticipated in the first quarter of 2022- SAN DIEGO, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Revelation Biosciences Inc. (Revelation), a
About this update from Revelation Biosciences, Inc.
[{"type":"text","content":"-Top-line data anticipated in the first quarter of 2022-\nSAN DIEGO, Nov. 15, 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 the initiation for its Phase 1b proof-of-concept nasal 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 without polyps. The study is being conducted in Australia and is enrolling individuals 18 to 55 years of age with a presumed history of allergic rhinitis to rye grass pollen. “Allergic rhinitis is one of the most common allergic respiratory disease types, impacting millions of people. Currently there are a limited number of therapies available, and we are excited about studying the potential of REVTx-99 as a new treatment option for patients in need” said James Rolke, Chief Executive Officer of Revelation. 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, 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 (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). Revelation expects the topline data in the fi...