ReViral Initiates Phase 1 Clinical Trial of Potent Oral Inhibitor Against Respiratory Syncytial Virus
London, UK, 31st October 2016 / Sciad Newswire / ReViral, an antiviral drug discovery and development company developing innovative therapies against Respiratory Syncytial Virus (RSV), announced today the initiation of a Phase 1 clinical trial for RV521, its novel orally-active small molecule inhibitor of RSV fusion. RSV infection is an area of significant unmet medical need and RV521 is being developed to treat RSV in patients with severe disease including neonates, the elderly, the immunocompromised and those with underlying cardiovascular or respiratory disease.
Rachel Harland, COO of ReViral, said “We’re very pleased to have initiated our Phase 1 study on RV521 and eagerly await the demonstration that the drug is suitable for progression to further clinical studies in infected patients.”
Eddy Littler, CEO of ReViral, said “The progression of RV521 to the clinic is a significant achievement for the Company and marks a major step forward in developing a potential new therapy against RSV. We’re also progressing other exciting early-stage programmes against RSV based on different mechanisms than that of RV521.”
ReViral’s RV521 Phase 1 clinical trial will evaluate the safety, tolerability, and pharmacokinetics of single ascending and multiple ascending oral doses of RV521, as well as the effect of food on drug absorption. The trial will enrol up to 110 healthy volunteers, including some of Japanese origin.
Each year, on average, in the United States, RSV leads to 57,527 hospitalisations among children younger than five years old; 2.1 million outpatient visits among children younger than five years old; 177,000 hospitalisations and 14,000 deaths among adults older than 65 years. By 2024 current estimates suggest that the worldwide RSV market will be worth over $2B (GlobalData, 2016).
In preclinical studies, RV521 has been shown to potently inhibit RSV replication in both cultured human cells and in in vivo models(1). Moreover, during in vitro studies, only low levels of virus resistance to RV521 were observed. Pre-clinical studies demonstrated that RV521 has good exposure and low toxicity. Altogether these observations support the potential of RV521 in the treatment of infection in all susceptible populations.
(1) THE PRECLINICAL CHARACTERISATION OF RV521, AN ORALLY BIOAVAILABLE INHIBITOR OF RSV. Cockerill S., et al; RSV16 10th International Respiratory Syncytial Virus Symposium, Patagonia, Argentina. 29th September 2016, Poster 139
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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 includes a number of Japanese volunteers. The Japanese pharmaceutical market is the second largest behind the US, and information obtained from Japanese volunteers is essential to ensure rapid future development.
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.
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