Challenge trial will evaluate RV521 in approximately 70 volunteers
LONDON--(BUSINESS WIRE)--ReViral, a UK-based biotech company focused on developing novel compounds targeting respiratory syncytial virus (RSV), announces that the first subjects have been dosed in a Phase 2a challenge study evaluating RV521 as an orally administered treatment for RSV infection. ReViral expects to report top-line data from this trial in early 2018.
RV521 is a potent, orally available, inhibitor of the RSV fusion (F) protein, with promising pharmaceutical properties. It is currently in development for the treatment of RSV disease in paedriatrics, the elderly and immune-compromised patients.
The trial plans to inoculate approximately 70 adult volunteers with RSV to investigate the efficacy, safety, and dose-response of orally delivered RV521 for the treatment of the disease. The primary endpoint of this double-blind, placebo-controlled study, is a reduction of viral load for RV521 compared to placebo, as measured by PCR analysis of nasal washes, a standard measure of virus replication in this model.
The trial will be conducted at a site in London, UK, and will provide data to inform further development and commercial strategy.
“Dosing our first subjects in this proof of concept study is a major step forward in the evaluation of RV521 as a novel therapy for RSV infected patients, an area of significant unmet medical need,” said Eddy Littler, PhD, CEO of ReViral. “The Phase 1 clinical data generated to date for RV521 makes it a promising best-in-class treatment option. We look forward to the results of this challenge study and expect to report top-line results in early 2018.”
Previously, ReViral conducted a UK-based Phase 1 safety and pharmacokinetic (PK) study of RV521. In the multiple ascending dose (MAD) phase, groups of 8 subjects were dosed with either RV521 (at doses of 175, 250 or 350 mg bid) or placebo (3:1 ratio) for five consecutive days. There were no significant adverse events reported in any subject at any dose level. Optimal RV521 exposure was achieved after the first dose, and pharmacokinetic (PK) parameters were consistent with predicted values modelled from the single ascending dose (SAD) data.
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About ReViral
ReViral is an antiviral drug discovery, and development company focused on novel treatments for diseases caused by the respiratory syncytial virus (RSV).
Founded in 2011, ReViral has an experienced R&D leadership team with a successful track record in antiviral drug discovery and development. The company has developed a novel antiviral programme targeting RSV fusion with highly potent, orally bioavailable inhibitors, strong drug-like characteristics and good pharmacokinetic properties offering versatility in route of administration. ReViral’s Phase 1 clinical trial will include Japanese volunteers.
In 2012 ReViral won a significant Seeding Drug Discovery Award from the Wellcome Trust to develop its RSV fusion inhibitors to completion of IND filing. The company also has an RSV replication programme at an earlier stage of development and plans to expand its pipeline. In September 2015, ReViral completed a $21 million Series A funding round from a group of leading venture capital investors including Edmond de Rothschild Investment Partners, OrbiMed, and Brace Pharma Capital.
ReViral has a portfolio of RSV compounds in development with mechanisms based on inhibition of virus replication. The replication inhibitors will provide a potential combination therapy which would include RV521.
About RSV
RSV causes substantial mortality and morbidity among infants and children under the age of 2 years, with an estimated annual incidence >3.5 million in the USA. Worldwide mortality rates in children under five years of age are estimated at 200,000, and there are infant deaths occurring in the US every year with reported numbers ranging from 500-4,500.
Bronchiolitis, due to RSV, is the most common cause of hospitalisation among infants during the first 12 months of life, and an estimated 310,000 cases of children under five are hospitalised per annum in the United States and EU. There is also a strong association between RSV infection in infants and recurrent wheezing, as well as reported increased rates of asthma, later in childhood. Infection in young adults also occurs, but both the frequency and severity are lower than that observed in young children.
RSV causes a significant disease burden in the elderly particularly those with respiratory or cardiac co-morbidities. RSV is a leading cause of morbidity and mortality in this population, with an estimated 175,000 hospitalisations and 10,000 deaths in the US annually.
RSV poses a serious threat to adult patients who are immunosuppressed following lung or haemopoietic stem cell transplantation (SCT) with a reported 10-17% of SCT patients contracting RSV. Adults with chronic respiratory disease are a high-risk population, with over 25% of patients with chronic obstructive pulmonary disease (COPD) diagnosed with RSV during exacerbations, which can lead to serious often fatal pneumonia.
