Merck Initiates Phase 3 Study of Letermovir for Prevention of Cytomegalovirus (CMV) Infection
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- July 24, 2014 -- Merck, known as MSD outside the United States and Canada, today 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.
"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 Rubsamen-Schaeff, CEO of AiCuris. "We are very excited to have reached this stage and look forward to the results."
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.
To learn more about the study, please contact Merck at 1-888-577-8839 or visit www.merck.com/clinical-trials. Additional details can also be found online at www.clinicaltrials.gov/ct2/show/NCT02137772.
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. Letermovir has been granted Orphan Product Designation by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the prevention of CMV viremia and disease in at-risk populations and also has been granted Fast Track Status by the FDA.
Under an agreement signed in 2012, Merck (through a subsidiary) purchased worldwide rights to develop and commercialize letermovir from AiCuris GmbH & Co KG (www.aicuris.com).
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. Two main strategies to prevent CMV infection in transplant recipients at risk have been adopted: anti-CMV drug prophylaxis or surveillance and pre-emptive treatment of transplant recipients with evidence of CMV viremia.
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Source: Merck & Co., Inc.
Posted: July 2014