Partnering/Licensing Opportunity for Tecarfarin, a Phase 3-Ready Oral Anticoagulant for Patients with Certain Orphan Diseases

Cadrenal Therapeutics (www.cadrenal.com; NASDAQ: CVKD) is a public U.S. company focused on advancing the development and commercialization of Tecarfarin with an initial indication for the prevention of systemic thromboembolism in patients with end-stage kidney disease (ESKD) and atrial fibrillation (ESKD+AFib), for which tecarfarin has received both FDA orphan drug and fast track designations. 

The anticoagulation of patients with left-ventricular assist devices (LVADs) and the treatment of Antiphospholipid Syndrome (APS) are two additional orphan indications for life cycle management, both of which Cadrenal is evaluating for orphan desgination. In all three of these indications, warfarin fails to achieve sufficiently stable anticoagulation and direct-acting oral anticoagulants or DOACs (Eliquis-class drugs) are not indicated because warfarin and apixaban may cause substantial harm, leading to outcomes such as stroke, systemic embolism, major bleeding, or death. Consequently, over 50% of patients of these patients receive no anticoagulation at all.

Tecarfarin is a novel Vitamin K antagonist that has been specifically and deliberately designed to provide more stable anticoagulation than warfarin, thereby decreasing the risk of stroke and bleeding. Unlike warfarin, tecarfarin is metabolized by esterases, escaping metabolism by the cytochrome P450 system and thereby avoiding CYP450-mediated drug-drug or drug-food interactions as well as genetic variations found in the CYPP450 system. Notably, chronic kidney disease did not adversely affect the metabolism of tecarfarin as it did with warfarin in a head-to-head Phase 1 PK trial.

Tecarfarin is intended for indications for which warfarin fails to achieve sufficiently stable anticoagulation and DOACs (Eliquis-class drugs) are not indicated. Once approved, Cadrenal anticipates a rapid uptake in prescriptions of tecarfarin particularly in patients that receive no anticoagulation whatsoever. Cadrenal also anticipates premium pricing reflecting the value of improved anticoagulation in these three orphan patient populations.

Tecarfarin has been evaluated in eleven (11) human clinical trials and over 1,003 subjects. Tecarfarin has generally been well-tolerated in both healthy adult patients and patients with chronic kidney disease or CKD. Based on this extensive safety record and FDA guidance, the basis of approval will be the results of a single pivotal Phase 3 placebo-controlled trial of tecarfarin in ESKD + AFib.These patients have typically been excluded from randomized clinical trials because approved therapies for AFib have metabolic profiles that may increase drug exposures in patients, thereby increasing known risks and challenges in managing patients with ESKD + AFib.

Cadrenal appointed The Sage Group to assist in partnering Tecarfarin.