Advances knowledge about the use of tecarfarin in patients with severe kidney impairment, including dialysis
Pivotal step forward in pursuit of ESKD + Atrial Fibrillation (AFib) registration trial
Addresses a critical current treatment gap in patients with ESKD
Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company focused on developing transformative therapeutics that specifically address limitations of current anticoagulation therapy, today announced clinical trial initiation plans for its lead late-stage drug candidate, tecarfarin, in patients with ESKD who are transitioning to dialysis. Enrollment is planned to begin later this year and will include patients with and without atrial fibrillation (AFib).
Patients with severe kidney disease are already at high risk for thrombotic cardiovascular events such as myocardial infarction and stroke, along with a much greater risk of AFib and venous thromboembolism compared to subjects with normal kidney function. When ESKD patients require dialysis, their transition period comes with even greater risk of myocardial infarction, stroke, and a substantial increase in mortality.
“There is a critical need for safe, effective anticoagulants for use in ESKD patients,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “Tecarfarin’s orphan drug and fast-track designations in ESKD patients with AFib underscore this need, and we are excited to advance this program. This study will be an important step forward for the continued development of tecarfarin in ESKD and in other areas with real opportunities to improve patient outcomes with a potentially better vitamin K antagonist.”
Currently, there is limited evidence supporting the use of anticoagulant therapy in dialysis patients. Dialysis patients are often excluded from clinical trials due to their high underlying risk profile, and studies of direct oral anticoagulants (DOACs) in this patient population have not provided clear answers. Furthermore, a recent Phase 2 trial of chronic hemodialysis patients sponsored by a global company showed no benefit from the new class of Factor XI inhibitors in maintaining vascular access graft patency. To date, no prospective studies have examined the benefit of oral anticoagulation in preventing thrombotic events at the time of dialysis initiation.
“Initiating dialysis carries substantial excess risk of cardiovascular events and mortality, and to date, this risk has not been sufficiently addressed. Tecarfarin, a next-generation Vitamin K antagonist with a unique metabolism pathway that is not significantly affected by kidney impairment, has potential promise in this area of unmet need,” said Wolfgang Winkelmayer, Professor of Medicine and Chief of Nephrology at Baylor College of Medicine in Houston, Texas.
