What Is Abelacimab?
Abelacimab is an investigational drug currently being studied in clinical trials. It is being developed by Anthos Therapeutics, Inc. The specific mechanism of action of Abelacimab is not detailed in the provided trial descriptions, but it is being investigated for its potential role in preventing and treating conditions related to blood clot formation. As of the latest data, Abelacimab is being studied in 4 clinical trials with a total enrollment of 4,754 participants. The first trial began in 2021, and the latest started in 2023. It is provided as a liquid in a vial, typically at a concentration of 150 mg/mL.
Uses and Conditions Under Study
Abelacimab is being investigated for several conditions primarily related to blood clot prevention and treatment. These conditions fall into two main categories:
- Venous Thromboembolism (VTE) and related conditions: This category includes Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE). DVT is a blood clot that forms in a deep vein, usually in the leg, while PE occurs when a part of that clot breaks off and travels to the lungs. Venous Thromboembolism is a general term for these conditions. Abelacimab is being studied for these conditions in 2 trials each, suggesting its potential as an anticoagulant to prevent or treat these dangerous clots.
- Atrial Fibrillation (AF) and Stroke: Atrial Fibrillation is an irregular and often rapid heart rhythm that can increase the risk of stroke, as it can lead to blood clots forming in the heart that then travel to the brain. Stroke is a serious condition caused by a disruption of blood flow to the brain, often due to a clot. Abelacimab is being investigated for Atrial Fibrillation in 2 trials and for Stroke in 1 trial, indicating its potential to prevent clot-related strokes in patients with AF.
Dosing
Abelacimab has been studied in clinical trials as a liquid formulation. It is provided as a liquid in a vial at a concentration of 150 mg/mL. The investigational product is also referred to by its code, MAA868. Different strengths of Abelacimab have been studied in trials, including 90 mg and 150 mg doses. These doses are being evaluated for their effectiveness and safety across the various conditions under investigation, such as Atrial Fibrillation and Venous Thromboembolism. The specific frequency and method of administration (e.g., intravenously or subcutaneously) are determined by the design of each individual clinical trial. Information regarding standard adult or pediatric doses is not available, as Abelacimab is still an investigational drug.
Side Effects
Information regarding the specific side effects of Abelacimab was not provided in the clinical trial data available for this drug reference. Clinical trials primarily focused on the efficacy and comparative bleeding rates of Abelacimab versus rivaroxaban, without detailing a comprehensive list of adverse events or their frequencies against a placebo.
Clinical Trial Results
Clinical trials have investigated Abelacimab, also known as MAA868, for its safety and tolerability in comparison to rivaroxaban in patients with atrial fibrillation. One key study, NCT04755283, focused on the incidence rates of various bleeding events.
One primary outcome measured the rate of major bleeding or clinically relevant non-major (CRNM) bleeding events. Patients receiving Abelacimab 90 mg experienced these events at a rate of 2.64 participants per 100 person-years. For the 150 mg dose of Abelacimab, the rate was 3.22 participants per 100 person-years. In comparison, patients taking rivaroxaban experienced these combined bleeding events at a rate of 8.39 participants per 100 person-years.
The study also specifically looked at the incidence rate of major bleeding events alone, as defined by the International Society on Thrombosis and Haemostasis (ISTH). The 90 mg dose of Abelacimab showed a rate of 0.99 participants per 100 person-years, while the 150 mg dose had a rate of 1.22 participants per 100 person-years. Rivaroxaban, in contrast, had a major bleeding event rate of 3.73 participants per 100 person-years.
Furthermore, the trial assessed the incidence rate of all bleeding events, including major, CRNM, and minor bleeding. Patients on Abelacimab 90 mg had a rate of 7.05 participants per 100 person-years. The 150 mg dose of Abelacimab resulted in a rate of 10.43 participants per 100 person-years. For patients treated with rivaroxaban, this broader category of bleeding events occurred at a rate of 15.30 participants per 100 person-years.
Across these bleeding outcomes, both doses of Abelacimab demonstrated lower incidence rates compared to rivaroxaban, with the 90 mg dose generally showing the lowest rates of bleeding events.
Currently Recruiting Trials
Clinical trials are crucial for developing new medicines and understanding their potential benefits for patients. Abelacimab is currently under investigation in a key study for individuals with a specific heart condition.
The LILAC-TIMI 76 study (NCT05712200) is a Phase 3 trial evaluating the efficacy and safety of abelacimab. This study focuses on patients with Atrial Fibrillation (AF) who have been deemed unsuitable for oral anticoagulation. Researchers are comparing abelacimab to a placebo to assess its effect on the rate of ischemic stroke or systemic embolism. The trial aims to enroll approximately 1,900 participants and is sponsored by Anthos Therapeutics, Inc.
Where to Participate
The LILAC-TIMI 76 study for abelacimab is broadly accessible across the United States, with 150 sites located in 132 cities across 33 states. Top participating locations include:
- Houston, Texas
- Birmingham, Alabama
- Ocala, Florida
- Hollywood, Florida
- Baltimore, Maryland
- Tamarac, Florida
- Rockville, Maryland
- Saint Augustine, Florida
- Las Vegas, Nevada
- Clearwater, Florida
To be eligible for this trial, participants must be between 65 and 65 years old. The study is open to all genders, but it does not include healthy volunteers or children.
Development Timeline
The development journey for abelacimab began on February 16, 2021, with its first clinical trial. Since then, Anthos Therapeutics, Inc. has consistently driven its research, sponsoring all four trials conducted to date. Initially, abelacimab was investigated for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the research expanded into new therapeutic areas, reflecting a broader potential for the drug. The pipeline grew to include studies for serious conditions like Pulmonary Embolism, Venous Thromboembolism, and Stroke. The latest trial started on February 3, 2023. This progression shows a strategic shift towards addressing cardiovascular and thrombotic disorders. Across all studies, abelacimab has involved a total of 4,754 participants, progressing through one Phase 2 trial and three Phase 3 trials, indicating significant advancement in its clinical development.