Date: 2014-07-24
Type of information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Merck&Co (USA) Aicuris (Germany)
Product: letermovir (MK-8228)
Action
mechanism: Letermovir (AIC246) is a highly active and specific inhibitor of HCMV. It stems from a novel chemical class (quinazolines) and addresses a novel target (the viral terminase). Based on this new mode of action, it retains full activity also against viruses which are resistant to marketed drugs (invariably inhibitors of the viral polymerase). Under an agreement signed in 2012, Merck purchased worldwide rights to develop and commercialize letermovir from AiCuris. Letermovir has received Orphan Drug Status in the US and EU and Fast Track Designation in the US.
Disease: prevention of clinically-significant cytomegalovirus (CMV) infection in adult (18 years and older) CMV-seropositive recipients of allogeneic hematopoietic stem cell transplants
Therapeutic area: Infectious diseases
Country: USA, Austria, Belgium, Canada, France
Trial
details: The study will evaluate the efficacy and safety of MK-8228 for the prevention of clinically-significant CMV infection in adult, CMV-seropositive recipients of allogeneic hematopoietic stem cell transplant. The hypothesis being tested is that MK-8228 is superior to placebo in the prevention of clinically-significant CMV infection through 24 weeks after transplant. (NCT02137772)
Latest
news: * On July 24, 2014, Merck & Co announced that the first patient has been enrolled in a global Phase 3 clinical study of letermovir (MK-8228), an investigational antiviral agent. The multicenter, randomized, placebo-controlled study will evaluate the efficacy and safety of letermovir for the prevention of clinically-significant cytomegalovirus (CMV) infection in adult (18 years and older) CMV-seropositive recipients of allogeneic hematopoietic stem cell transplants. In the study, letermovir will be administered once daily, either as an oral tablet or IV formulation, for 14 weeks after transplant. The dose will be 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. The primary outcome measure of the study will be the percentage of participants with clinically-significant CMV infection through 24 weeks after transplant who were administered letermovir compared to placebo. Merck expects approximately 540 patients will be enrolled in the study at more than 70 centers in 20 countries, including the United States. The estimated study completion date is July 2017.
