Merck Initiates Phase 3 Study of Letermovir, an Investigational Antiviral
for Prevention of Cytomegalovirus (CMV) Infection in High-Risk Bone Marrow
WHITEHOUSE STATION, N.J. -- July 24, 2014
Merck (NYSE:MRK), 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 Rübsamen-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
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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