The failure of Astellas Pharma Inc. / Vical Inc.'s experimental vaccine ASP0113 to meet the main and secondary targets in a late-stage study of certain kidney transplant patients adds further momentum to Merck & Co. Inc.'s orphan drug Prevymis (letermovir), which recently won first-mover advantage to treat cytomegalovirus (CMV) in the US and Europe.
The Phase III HELIOS trial was designed to evaluate the efficacy of ASP0113 compared with placebo in CMV-seropositive recipients undergoing an allogeneic stem cell transplant. The primary endpoint of the trial - a composite of overall mortality and CMV end-organ disease assessed one year after transplantation – was not met
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