Investigational Anticoagulant Therapy Receives Fast Track Designation from FDA

The phase 2 study will evaluate the efficacy and safety of 2 different doses of MK-2060 in patients with ESRD receiving hemodialysis via an arteriovenous graft.

The FDA has granted Fast Track Designation to the investigational anticoagulant therapy MK-2060 (Merck) to reduce the risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).

MK-2060 is designed to stop Factor XI and its ability to activate downstream proteins involved in the blood coagulation cascade. The drug is also being evaluated in a phase 2 study for the treatment of patients with ESRD receiving hemodialysis.

“At Merck we are focusing our efforts where the needs are greatest, and we believe we have a significant opportunity with MK-2060 for the potential prevention of thrombosis in patients with advanced forms of kidney disease,” said Eliav Barr, MD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a press release. “We are encouraged by this Fast Track designation because additional anticoagulation medicines are urgently needed for patients with ESRD who are susceptible to high rates of life-threatening thrombotic events as well as high bleeding risk. Today there is no anticoagulation standard of care for such patients.”

MK-2060 is a novel inhibitor being examined for the prevention of thrombosis in patients with ESRD and is designed to work through a dual mechanism of action both blocking the activation of Factor XI and the downstream activity of activated protein.

The phase 2 study will evaluate the efficacy and safety of 2 different doses of MK-2060 in patients with ESRD receiving hemodialysis via an arteriovenous graft. The data collected in this trial will be used to aid dose selection of MK-2060 in future studies, according to Merck.

REFERENCE

Merck Receives Fast Track Designation from the U.S. FDA for MK-2060, an Investigational Anticoagulant Therapy. Merck. August 23, 2022. Accessed August 23, 2022. https://www.merck.com/news/merck-receives-fast-track-designation-from-the-u-s-fda-for-mk-2060-an-investigational-anticoagulant-therapy/