Merck & Co. says late-stage study of antiviral letermovir hits main goal

Merck & Co. announced Wednesday that a Phase III study of the experimental antiviral drug letermovir met its primary endpoint. The trial investigated the therapy for the prevention of clinically significant cytomegalovirus (CMV) infection in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.

In the study, patients were treated once daily with either intravenous or oral letermovir beginning no later than 28 days after allogeneic hematopoietic stem cell transplantation and continuing until about 100 days post-transplant. The main goal of the trial was the percentage of participants with clinically significant CMV infection through 24 weeks post-transplant.

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Roy Baynes, senior vice president of clinical development at Merck Research Laboratories, stated "there is an unmet need for therapeutic options in the prevention of CMV infection in high-risk allogeneic hematopoietic stem cell transplant recipients." Merck noted that results from the trial will be submitted for presentation at a future research conference.

Under an agreement signed in 2012, Merck purchased global rights to develop and commercialise letermovir from AiCuris. The drug was awarded fast track designation by the FDA in 2011 and given orphan drug status by the agency the following year. Letermovir has also been granted orphan drug designation by regulators in Europe and Japan. 

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