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Published On: Thu, Jul 24th, 2014

Merck announces start of Phase III study of CMV drug, Letermovir

Merck announced today 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.

cytomegalovirus  Image/CDC

cytomegalovirus
Image/CDC

“There remains a need for additional therapeutic options in the prevention of CMV infection in high-risk patients,” said Dr. Michele Trucksis, executive director, Infectious Diseases, Merck Research Laboratories. “Merck is pleased to initiate this global Phase 3 study with letermovir.”

“This study marks a very important step in the development of letermovir and for AiCuris as licensor of this compound,” said Prof. Helga Rübsamen-Schaeff, CEO of AiCuris. “We are very excited to have reached this stage and look forward to the results.”

Letermovir is an investigational once-daily antiviral agent under development for the prevention of human CMV infection. It is derived from a novel chemical class (quinazolines) and is designed to inhibit the human CMV viral terminase.

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.

CMV is widely spread in the human population and can cause severe, life-threatening infections in cases of immune incompetency or immune deficiency, such as, for example, in transplant recipients. CMV infection is characterized by fever, leukopenia (very low white blood cell count) and thrombocytopenia (very low platelet numbers) with or without specific organ dysfunction.

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