Ponte Vedra-based Cadrenal Therapeutics to begin late-stage trial for kidney drug (Courtesy of the Jacksonville Business Journal) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) is moving forward with a late-stage clinical trial for its lead drug candidate, tecarfarin, aimed at patients with end-stage kidney disease transitioning to dialysis.
The Ponte Vedra-based biopharmaceutical company said Tuesday enrollment will begin later this year and will include patients both with and without atrial fibrillation.
“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.”
Patients with severe kidney disease face heightened risks of heart attack, stroke, AFib and venous thromboembolism. That danger spikes during the transition to dialysis, when mortality rates and cardiovascular event risks climb significantly, the company said.
Currently, dialysis patients are often excluded from anticoagulant studies because of their high-risk profiles, leaving limited evidence for treatment effectiveness.
“Initiating dialysis carries substantial excess risk of cardiovascular events and mortality, and to date, this risk has not been sufficiently addressed,” said Wolfgang Winkelmayer, professor of medicine and chief of nephrology at Baylor College of Medicine, in a statement. “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.”
Tecarfarin has received multiple orphan drug designations and fast-track status from the U.S. Food and Drug Administration. Cadrenal made its debut on the Nasdaq stock exchange in January 2023.