Anti-viral drug discovery and development company ReViral has commenced a Phase 1 clinical trial for RV521, an orally active, small-molecule inhibitor of RSV fusion.
RSV infection has been an unmet medical need and RV521 is being developed to treat RSV in patients suffering with severe disease, including neonates, the elderly, the immunocompromised and those with underlying cardiovascular or respiratory disease.
ReViral COO Rachel Harland 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.”
ReViral CEO Eddy Littler 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 analyse the safety, tolerability, and pharmacokinetics of single-ascending and multiple-ascending oral doses of RV521 in addition to the impact of food on drug absorption.
The study will see the enrolment of up to 110 healthy volunteers.
Every year, in the US, 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.
In preclinical studies, RV521 has been shown to potently restrict RSV replication in both cultured human cells and in in-vivo models.
Furthermore, during in-vitro studies, only low levels of virus resistance to RV521 were observed.
Pre-clinical studies indicated 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.
Image: Electron micrograph depicting RSV pathogen. Photo: courtesy of Centers for Disease Control and Prevention's Public Health Image Library (PHIL).