FDA has informed Merck (NYSE:MRK) that its investigational anticoagulant therapy MK-2060 has received Fast Track designation. The program accelerates the review of new drugs to treat serious conditions or unmet medical need.
The Fast Track designation covers the risk reduction of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).
“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,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a news release. “Today, there is no anticoagulation standard of care for such patients.”
A Phase 2 Study of MK-2060 is now underway in people with end-stage renal disease who are undergoing hemodialysis.
The FXI hemodialysis study will test two different doses of the investigational anticoagulant therapy MK-2060. In addition, Merck will use data from the study to inform the dose selection of MK-2060 in future trials.
MK-2060 is an intravenously delivered factor XI inhibitor. The monoclonal antibody is also designed to activate downstream proteins involved in the blood coagulation cascade.
A handful of other companies are developing novel anticoagulation drug candidates, including Anthos Therapeutics, whose abelacimab antibody is in a Phase 3 study.
MRK shares were down about 1% to $90.20.
The company’s shares reached a 52-week high of $95.72 on June 27.
Last week, Merck announced a deal with Orna Therapeutics, which specializes in engineered circular RNA (oRNA) therapies. Creating oRNA involves modifying mRNA strands to form circles instead of lines.
Under the terms of that partnership, Merck will make an upfront payment of $150 million to Orna. In addition, the company could pay up to $3.5 billion in additional milestone-based payments.
Merck is also reportedly mulling the acquisition of Seagen (Nasdaq:SGEN).
Filed Under: Hematology
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