The monoclonal antibody is being investigated to reduce the risk of major thrombotic cardiovascular events in ESRD patients
MK-2060 is a new Factor XI inhibitor and has been designed to work through a dual mechanism of action by blocking the Factor XI activation and the downstream activity of activated protein.
Merck Research Laboratories chief medical officer, global clinical development head and senior vice-president Dr Eliav Barr said: “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.
“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.”
At present, MK-2060 is being assessed in a Phase II study to treat ESRD patients who are receiving hemodialysis through an arteriovenous graft (AVG).
In this study, the safety and efficacy of two different doses of MK-2060 is being evaluated in ESRD patients.
Merck stated that the data from the study will be utilised in the dose selection of MK-2060 in future studies.
In April this year, the company received UK’s National Institute for Health and Care Excellence (NICE) recommendation for tepmetko (tepotinib) to treat advanced non-small cell lung cancer (NSCLC) in adult patients.