ReViral, a UK based biotechnology company focused on the discovery and development of antivirals for respiratory syncytial virus (RSV), has announced top-line safety and pharmacokinetic (PK) data from the Phase I single and multiple ascending dose (SAD and MAD) trial of RV521.
RV521 is a novel oral fusion inhibitor in development for the treatment and prevention of RSV infections. It specifically inhibits RSV replication by blocking viral entry and cell to cell spread (syncytium formation).
RV521 demonstrates potent antiviral activity across multiple strains of RSV in vitro and represents a step forward in the development of effective therapeutics for this serious and potentially life-threatening infection.
Results from the trial indicated that RV521 was well tolerated at all dose levels; there were no significant treatment-related adverse events and no adverse changes in electrocardiograms or clinical laboratory values.
“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. 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,” stated Eddy Littler, PhD, Chief Executive Officer of ReViral.
ReViral also conducted a blinded multiple ascending dose (MAD) study in the UK evaluating the safety and PK of RV521 on three cohorts of healthy volunteers (175, 250 and 350 mg of RV521) dosed orally twice a day for 5 consecutive days.
Each of the dose cohorts consisted of six subjects who received RV521 and two who received a placebo.
There were no significant adverse events reported in any subject at any dose level. Optimal RV521 exposure was rapidly achieved with an excellent half-life and was consistent with 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. 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,” stated Ken Powell, PhD, Chairman of ReViral.