UK-based biotechnology company, ReViral, has announced top-line safety and pharmacokinetic (PK) data from the Phase I single and multiple ascending dose (SAD and MAD) trial of RV521.
Clinical trial abstract
RV521 is an oral fusion inhibitor that is being developed for the treatment and prevention of respiratory syncytial virus (RSV) infections. By blocking viral entry and cell to cell spread, the treatment inhibits RSV replication.
Results from the trial demonstrated that RV521 was well tolerated at all dose levels with no significant adverse events and no adverse changes in electrocardiograms or clinical laboratory values seen.
“This trial represents a significant step in the development of RV521 as an effective first-line antiviral therapy for RSV infection in infants and the elderly,” explained Eddy Littler, PhD, chief executive officer of ReViral. “We dosed a total of 48 subjects in the trial with good tolerance at all doses. Antiviral levels of RV521, more than 3xEC90, were rapidly achieved and maintained in the plasma.”
Moreover, the company evaluated the safety and PK of the therapy in a blinded multiple ascending dose study. In this study, three cohorts of healthy volunteers were administered with RV521 at differing dose levels orally twice a day for five consecutive days. Within each cohort six subjects received the therapy and two received placebo.
No significant adverse events were reported across all of the evaluated participants. Optimal exposure of the drug was achieved rapidly, which was consistent with the predicted values modelled from the SAD data.
“The results of our Phase I clinical trials show that RV521 is potentially a best in class inhibitor of RSV with good exposure at low doses and no significant adverse events,” added Ken Powell, PhD, chairman of ReViral. “I am very pleased that we have shown that RV521 can be administered simply by the oral route as, during infection, RSV causes a large amount of mucus to be produced limiting other methods of delivery. We are looking forward to starting our Phase IIa study next quarter.”