Merck has been granted a rare gift in the medical product approval process: the FDA has put a fast-track tag on its newest anticoagulant solution, a midphase asset XI/Xla inhibitor leveraging molecule MK-2060. The benediction will help Merck bring a standard-of-care anticoagulation therapy for end-stage renal disease (ESRD) patients to market in an accelerated timeline. The fast-track tag certifies use of MK-2060 to mitigate the significant thrombotic events common among ESRD patients.
The dual-factor XI/Xla inhibitor in play here has been fleshed out to address the needs of higher-risk ESRD patients; the lack of a top-shelf drug to help prevent blood clots in patients with higher bleeding risks will make Merck’s MK-2060 solution a godsend for providers. The prospective success rate of its clinical use is buoyed by research showing that patients with inherited factor XI deficiency carry a lower risk of thrombotic events with an increased risk of major bleeding.
Anticoagulation through factor XI is nothing new to the sector, and several other companies have tapped into it. Anthos Therapeutics, a Novartis offshoot, has its phase-three Abelacimab antibody, which like MK-2060 is able to inhibit both Xl and Xla. That program, however, is meant for treatment in cancer-related venous thromboembolism. Merck’s other competition in this endeavor includes Bayer, which is toying with a factor Xl antisense candidate, and Aronora, which beyond an adjacent collaboration with Bayer has brought forward phase-2 ESRD data on factor Xl candidate AB023.