Revelation Biosciences has commenced a Phase IIb study of its intranasal drop solution, REVTx-99, in healthy individuals to prevent H3N2 influenza (influenza A).
The solution is being developed to prevent or treat respiratory viral infections including influenza A, influenza B, respiratory syncytial virus (RSV), parainfluenza, rhinovirus and SARS-CoV-2, including its variants.
Through interaction with toll-like receptor 4 (TLR4), REVTx-99 boosts the nasal (mucosal) innate immune system for producing protective cytokines including interferons and related proteins.
The double-blind, randomised, placebo-controlled Phase IIb viral challenge study is being conducted in Belgium and will enrol up to 60 healthy individuals aged 18 to 55 years.
It will assess REVTx-99’s efficacy to prevent or treat H3N2 influenza in healthy individuals.
Evaluating the therapy’s ability in reducing influenza virus load in the upper airways at the time of infection will be the trial’s primary endpoint.
Symptoms’ duration, peak viral load, influenza virus presence duration, peak symptom score and area under the curve of total symptom score will be some of the secondary goals of the trial.
Other secondary goals will include incidence of mild to moderate influenza disease as well as seroconversion incidence.
Revelation Biosciences CEO James Rolke said: “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 hospitalisations and 22,000 deaths.
“The start of our viral challenge study is an important step in bringing a potential new therapy to bear on this problem.”
The company stated that the Phase IIb study is the next step in the clinical development of the intranasal solution to treat respiratory viral infections.
In the future, the REVTx-99 solution will also be evaluated in clinical studies to treat SARS-CoV-2 along with its variants and other respiratory viruses.
Last month, Pneumagen started the Phase I clinical trial of its intranasal drug, Neumifil, for the prophylaxis and treatment of viral respiratory tract infection.