Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Merck has enrolled first patient in a global Phase III clinical trial of letermovir (MK-8228), an investigational antiviral agent, for prevention of cytomegalovirus (CMV) infection in high-risk bone marrow transplant patients.
Subscribe to our email newsletter
The multicenter, randomized, placebo-controlled Phase II trial will evaluate the efficacy and safety of letermovir for the prevention of clinically-significant CMV infection in adult 18 years and older.
Letermovir, being developed for the prevention of human CMV infection, has received Orphan Product Designation by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the prevention of CMV viremia.
Merck Research Laboratories executive director of Infectious Diseases Michele Trucksis said there remains a need for additional therapeutic options in the prevention of CMV infection in high-risk patients.
"Merck is pleased to initiate this global Phase 3 study with letermovir," Trucksis said.
Merck along with its subsidiary has purchased worldwide rights to develop and commercialise letermovir from AiCuris in 2012.
In the trial, letermovir will be administered once daily, either as an oral tablet or intravenous (IV) formulation, for 14 weeks after transplant.
Letermovir 240 mg dose will be given once daily for patients who receive concomitant cyclosporin A and 480mg once daily for people not receiving cyclosporin A.
Primary outcome measure of the trial will be the percentage of participants with clinically-significant CMV infection through 24 weeks after transplant who were administered letermovir compared to placebo.
Around 540 patients at more than 70 centres in 20 countries, including the US, will be enrolled in the trial, which is expected to be completed in July 2017.