Cadrenal Therapeutics is set to advance its investigational drug, tecarfarin, into a pivotal Phase 3 clinical trial for patients with left ventricular assist devices (LVADs) in 2025. This follows a productive year for the company, marked by significant engagement with the FDA and strategic collaborations aimed at refining the clinical development pathway for tecarfarin.
The company held a Type B meeting with the FDA to discuss the Phase 3 clinical trial protocol for tecarfarin in LVAD patients. Further updates on the anticipated trial are expected in Q1 2025, as Cadrenal continues to work closely with the FDA to finalize trial details.
Strategic Collaborations and Financial Growth
Cadrenal Therapeutics is actively pursuing collaborations with potential development partners to bolster the advancement of tecarfarin's pivotal clinical trial, not only for LVAD patients but also for those with other rare cardiovascular conditions. Recent financing transactions, including an at-the-market (ATM) facility and warrant exercises, have increased the company's cash balance to $11.3 million as of November 2024.
Industry Recognition and Engagement
Cadrenal Therapeutics joined the Corporate Council of the Anticoagulation Forum (AC Forum) in October 2024, enabling collaboration with anticoagulation therapy thought leaders and healthcare professionals to improve anticoagulation outcomes globally. The company was also named Anticoagulation Therapy Company of the Year by Pharma Tech Outlook.
Operational Readiness and Market Research
The company and its pharmaceutical Contract Development and Manufacturing Organization (CDMO) have completed operational readiness activities to supply clinical trial materials for the upcoming tecarfarin Phase 3 trial, adhering to current Good Manufacturing Practices (cGMP). Market research across multiple indications, including LVAD, reinforces Cadrenal Therapeutics' commitment to pre-commercial work for tecarfarin.
Orphan Drug Designation and Clinical Evidence
Tecarfarin has received FDA Orphan Drug Designation (ODD) for preventing thromboembolism in LVAD patients and other mechanical circulatory support devices. It also holds ODD and Fast Track designation for preventing systemic thromboembolism of cardiac origin in end-stage kidney disease (ESKD) patients with atrial fibrillation (AFib).
Scientific Advocacy
The clinical need for tecarfarin was highlighted at the European Association for Cardio-Thoracic Surgery (EACTS) Mechanical Circulatory Support Summit by Mandeep R. Mehra, MD, who presented data on the limitations of warfarin for LVAD patients and the potential of tecarfarin as a safer alternative.
Tecarfarin, a vitamin K antagonist (VKA), is designed to be a superior and safer chronic oral anticoagulant therapy compared to warfarin for patients with implanted cardiac devices or rare cardiovascular conditions. Clinical data suggests that tecarfarin may offer fewer adverse events, such as strokes, heart attacks, bleeds, and deaths, compared to warfarin.
