Gilead’s Veklury blazed a trial for Covid-19 antivirals, but there remains much room for improvement: final results from a pivotal trial have confirmed the drug’s modest benefits, with a narrow group of patients benefiting the most. A couple of oral antivirals are seeking to offer more, and Merck & Co’s Ridgeback-partnered MK-4482, or molnupiravir, is most advanced. Two phase IIb studies are poised to start, recruiting almost 2,000 subjects. Meanwhile phase II data should emerge any day; these studies initially tested 200mg and 300mg, but higher doses were added, delaying readout. According to clinicaltrials.gov 200mg, 400mg and 800mg will be taken in phase IIb. Elsewhere, the first data on Biocryst’s galidesivir are also due later this year, from a phase I trial conducted in Brazil. And, while this is not strictly an antiviral, but said to have those properties, Abivax’s ABX494 is in the 1,000-patient Mir-Age trial. Finding a survival benefit remains the ultimate goal for any Covid-19 treatment, and while antibody approaches are considered more likely to hit this mark the cost and convenience advantages of these small-molecule antivirals should not be underestimated.
|Covid-19 antivirals – ones to watch|
|MK-4482||Merck & Co (Ridgeback)||Viral RNA polymerase inhibitor||Phase IIb in hospitalised and non-hospitalised patients; endpoints include mortality and recovery measures to day 29; recruitment starts late Oct||NCT04575584; NCT04575597|
|ABX464||Abivax||RNA CBC regulator; miRNA-124 expression stimulant; Rev inhibitor||Trial selects for high risk patients; primary endpoint rate of patients not requiring mechanical ventilation and who are alive; interim analysis, after 300 subjects, due YE'20; final readout Q1'21||NCT04393038|
|Galidesivir||Biocryst||Viral RNA polymerase inhibitor||BARDA/NIAID sponsored; phase I results will determine push into phase II||NCT03891420|
|Source: EvaluatePharma, company statements, clinicaltrials.gov.|