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Revelation Biosciences Inc. Receives Approval to Initiate Phase 2b Viral Challenge Study of REVTx 99, an Experimental Prophylactic Treatment for the Prevention of Respiratory Viral Infections
- Phase 2b study will investigate the efficacy of REVTx-99 on viral load and patient-reported flu symptoms- - Top-line data anticipated in the second quarter
About this update from Revelation Biosciences, Inc.
[{"type":"text","content":"- Phase 2b study will investigate the efficacy of REVTx-99 on viral load and patient-reported flu symptoms- - Top-line data anticipated in the second quarter of 2022 - SAN DIEGO, Sept. 28, 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 received approval from the Federal Agency for Medicines and Health Products (FAMHP) and the local Committee of Medical Ethics in Belgium to conduct a Phase 2b influenza viral challenge study. The Phase 2b, randomized, double-blind, influenza viral challenge study (RVL-VRL01) is planned in healthy volunteers. This viral challenge investigation will evaluate the potential efficacy of a single- and repeat-dose (twice) of REVTx-99 prophylaxis versus placebo on viral load and clinical illness influenza symptoms (Influenza Patient-reported Outcome (FLU-PRO) questionnaire). The study will include up to 60 participants and is expected to begin enrolling participants in the first quarter of 2022 with top-line data in the second quarter of 2022. Success in this type of viral challenge study may be predictive of future activity in later stage real-world field studies. “We have spent far too long accepting the deadly and economic impacts of respiratory viruses, including influenza, as something we have to live with,” said James Rolke, Chief Executive Officer of Revelation Biosciences. “COVID-19 has highlighted the global need for new solutions that address respiratory viruses and their many inevitable variants. The results of this viral challenge study are an important step in the development of REVTx-99 for the potential prevention and treatment of respiratory viral infections, like influenza and COVID-19.” An initial Phase 1 clinical study (RVL-NHV01) was conducted in healthy volunteers to evaluate the safety and tolerability of REVTx-99 as well as its effect on levels of intranasal cytokines. The study consisted of 5 single ascending cohorts oof single escalating doses and repeat doses of REVTx-99. In addition, in this study, 40 healthy participants were dosed in five ascending single dose cohorts and 8 healthy participants were dosed at the highest dose daily for 5 days. REVTx-99 was well tolerated with no significa...