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Revelation Biosciences Inc. Announces Initiation of a Phase 2b Study to Assess Efficacy of Intranasal REVTx-99 for The Prevention of H3N2 Influenza
Top-line data anticipated in the second quarter of 2022 SAN DIEGO, Dec. 01, 2021 (GLOBE NEWSWIRE) -- Revelation Biosciences Inc. (Revelation), a
About this update from Revelation Biosciences, Inc.
[{"type":"text","content":"Top-line data anticipated in the second quarter of 2022\nSAN DIEGO, Dec. 01, 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 site initiation for its Phase 2b viral challenge study (RVL-VRL01) to evaluate the efficacy of intranasal REVTx-99 for the preventive treatment of H3N2 influenza (influenza A) in healthy humans. The study is being conducted in Belgium and is enrolling healthy individuals 18 to 55 years of age. REVTx-99 activates a nonspecific immune response (innate) which differentiates it from most current treatments focused on a specific immune response (adaptive) potentially allowing for broader use in most infectious viruses. The viral challenge study is the next necessary step in clinical development of REXTx-99 for the treatment of respiratory viral infections. Future development plans include clinical studies in SARS-CoV-2 and its variants, along with other respiratory viruses. “Respiratory viral infections including COVID-19 and influenza continue to be a huge social and economic burden leading to more doctor visits and absenteeism from school and work than any other illness. For influenza, during the 2019-2020 season, the CDC estimates that influenza was associated with 38 million illnesses, 18 million medical visits, 405,000 hospitalizations, and 22,000 deaths,” said James Rolke, Chief Executive Officer of Revelation. “The start of our viral challenge study is an important step in bringing a potential new therapy to bear on this problem.” The Phase 2b, randomized, double-blind, placebo-controlled study will enroll up to 60 participants. The primary endpoint is to evaluate the efficacy of REVTx-99 in reducing influenza virus load in the upper airways during infection. Key secondary endpoints include: area under the curve (AUC) of total symptom score, duration of symptoms, peak symptom score, peak viral load, duration of influenza virus presence, incidence of mild to moderate influenza disease (MMID) and incidence of seroconversion. The study will have two randomized cohorts. Efficacy of the interventional strategies shall be assessed by measuring the incidence and severity of the disease in the active treatment groups compared ...