Benzinga | Jan 20, 2022 09:07AM EST

Revelation Biosciences Inc. Announces First Group Of Patients Dosed In Phase 2b Viral Challenge Study To Assess Efficacy Of Intranasal REVTx-99 For The Prevention Of H3N2 Influenza Infection

Revelation Biosciences Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company that is focused on the development of immunologicbased therapies for the prevention and treatment of disease, announced today that the first group of 15 patients have been enrolled and dosed in a Phase 2b viral challenge study (RVL-VRL01) to evaluate the efficacy of intranasal REVTx-99 for the preventive treatment of H3N2 influenza (influenza A) infection 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 REVTx-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.

"With respiratory viral infections like influenza, COVID-19, and its emerging variants there is a huge need for new therapies," said James Rolke, Chief Executive Officer of Revelation. "The results of this study will be an important step in the development of REVTx-99. Despite having vaccines, there remains an urgent need for multiple therapeutic approaches to help prevent and treat respiratory viral infections."

The Phase 2b, randomized, double-blind, placebo-controlled study will enroll up to 60 participants (four groups of 15 patients). The primary endpoint is to evaluate the efficacy of REVTx-99 in reducing area under the curve (AUC) influenza viral load in the upper airways during infection. Key secondary endpoints include: 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 multiple and single dose 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 to the placebo group along with parameters of safety associated with adverse events and airway physiology.

Revelation expects the topline data in the second quarter of 2022.

For more information on Revelation, please visit www.RevBiosciences.com.