Cadrenal Therapeutics, Inc. cited recent data that underscores additional need for an improved Vitamin K Antagonist (VKA). The Company believes tecarfarin is the solution for this unmet need. At the recent European Society of Cardiology Congress (ESC) in Amsterdam, The Netherlands, the open-label "FRAIL-AF" trial was presented, revealing that switching International Normalized Ratio (INR)-guided VKA treatment to direct oral anticoagulants (DOACs aka NOACs) in frail older patients with Atrial Fibrillation (AFib) was associated with more bleeding complications compared to continuing VKA treatment, without an associated reduction in thromboembolic complications.

Reports indicate that this unique trial was stopped early for utility in seeking superiority for the direct oral anticoagulant (DOAC) strategy. FRAIL-AF was deemed the most important study from ESC, according to Medscape. In the report, study author Geert-Jan Geersing, MD, PhD, of the University Medical Center Utrecht in the Netherlands, at the ESC Congress concluded that "Switching from a VKA to a NOAC should not be considered without a clear indication in frail older patients with AFib." Cadrenal is developing tecarfarin, a novel Vitamin K Antagonist, targeted for indications where existing VKA failure to achieve sufficiently stable anticoagulation and DOACs (Eliquis-class drugs) are not widely prescribed.

Currently, tecarfarin has orphan drug and Fast Track designations for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with ESKD and AFib, providing for 7-year marketing exclusivity.