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Human Igg4 S228P Monoclonal Antibody Against Factor Xi And Activated Factor Xi

This article discusses the clinical trials of REGN7508, a human IgG4 S228P monoclonal antibody targeting Factor XI and activated Factor XI. The drug is being studied for its potential to prevent venous thromboembolism (VTE) in patients with peripherally inserted central catheters (PICCs). The trials aim to assess the drug’s efficacy, safety, and tolerability in this patient population.

Table of Contents

What is REGN7508?

REGN7508 is a new medication being studied for its potential to prevent blood clots in patients who have a special type of intravenous line called a Peripherally Inserted Central Catheter (PICC)[1]. It’s important to understand that this drug is still in the testing phase and is not yet approved for general use.

The full name of REGN7508 is quite complex: Human IgG4 S228P Monoclonal Antibody Against Factor XI and Activated Factor XI[1]. Let’s break this down:

  • Human IgG4: This means it’s a type of antibody naturally found in humans.
  • S228P: This refers to a specific modification made to the antibody to improve its effectiveness.
  • Monoclonal Antibody: This means it’s a laboratory-made protein that targets a specific substance in the body.
  • Factor XI and Activated Factor XI: These are proteins in our blood that play a role in blood clotting.

How Does REGN7508 Work?

REGN7508 works by targeting and blocking the action of Factor XI and its activated form in the blood[1]. Factor XI is a protein that helps blood to clot. By inhibiting this factor, REGN7508 may help prevent unwanted blood clots from forming, especially in patients who have a PICC line.

A PICC line is a thin, flexible tube that’s inserted into a vein in your arm and threaded up to larger veins near your heart. It’s used to give medications, fluids, or take blood samples over an extended period. However, having a PICC line can increase the risk of developing blood clots, which is why medications like REGN7508 are being studied[1].

What Conditions Does REGN7508 Treat?

The main condition that REGN7508 is being studied for is the prevention of Venous Thromboembolism (VTE)[1]. VTE is a term that includes two related conditions:

  1. Deep Vein Thrombosis (DVT): This is when a blood clot forms in a deep vein, usually in the leg or arm.
  2. Pulmonary Embolism (PE): This occurs when a blood clot breaks off and travels to the lungs, which can be life-threatening.

Specifically, the clinical trial is focusing on preventing VTE in patients who have a PICC line, as these patients are at higher risk for developing blood clots[1].

Clinical Trial Details

The clinical trial for REGN7508 is a Phase 2 study, which means it’s still in a relatively early stage of testing[1]. Here are some key details about the trial:

  • It’s a randomized, double-blind, placebo-controlled study. This means that participants are randomly assigned to receive either REGN7508 or a placebo (a substance with no active ingredients), and neither the participants nor the researchers know who is receiving which.
  • The trial is comparing REGN7508 to a placebo to see how well it works and how safe it is.
  • The medication is given as a single intravenous (IV) dose.
  • The study is looking at how the drug moves through the body (pharmacokinetics) and how it affects the body (pharmacodynamics).

Who Can Participate in the Trial?

The trial has specific criteria for who can participate. Some of the main inclusion criteria are[1]:

  • Adults who are having a PICC line placed and expect to have it for at least 14 days
  • Body weight between 50 kg and 130 kg
  • Normal blood clotting test results
  • Adequate platelet count (platelets are blood cells that help with clotting)

Some reasons why a person might not be able to participate include[1]:

  • History of blood clots or bleeding disorders
  • Need for other blood-thinning medications
  • History of certain types of bleeding, such as in the brain or eye
  • Certain types of cancer treatments that can severely lower platelet counts

What Are the Expected Outcomes?

The main things the researchers are looking at (called “endpoints”) include[1]:

  • How many participants develop blood clots
  • How many participants experience side effects and how severe they are
  • How the drug affects blood clotting tests
  • How the body processes the drug
  • Whether the body develops antibodies against the drug

Safety Considerations

As with any new medication, safety is a top priority. The researchers will be closely monitoring for any side effects, particularly bleeding. They will be looking at[1]:

  • Major bleeding events
  • Clinically relevant non-major bleeding (less severe bleeding that still requires medical attention)
  • Any other adverse events that occur during the study

It’s important to remember that REGN7508 is still in the testing phase. While it shows promise for preventing blood clots in patients with PICC lines, more research is needed to fully understand its effectiveness and safety. If you’re interested in learning more or potentially participating in this or similar clinical trials, it’s best to discuss this with your healthcare provider.

Aspect Details
Drug Name REGN7508 (Human IgG4 S228P Monoclonal Antibody Against Factor XI and Activated Factor XI)
Trial Phase Phase 2
Trial Design Randomized, Double-blind, Placebo-controlled
Main Objective Evaluate efficacy for VTE prevention after PICC placement and assess safety/tolerability
Key Inclusion Criteria PICC expected to remain for ≥14 days, ECOG ≤2, weight 50-130 kg
Key Exclusion Criteria History of venous thrombosis, thromboembolic disease, or bleeding disorders
Primary Endpoints Incidence of confirmed VTE, incidence and severity of adverse events
Secondary Endpoints PICC-associated thrombosis, bleeding events, pharmacokinetics, pharmacodynamics, immunogenicity
Administration Single intravenous infusion
Therapeutic Areas Cardiovascular Diseases, Hemic and Lymphatic Diseases

FAQ

  • What is REGN7508? REGN7508 is a human IgG4 S228P monoclonal antibody that targets Factor XI and activated Factor XI. It is being studied as a potential treatment to prevent blood clots in patients with peripherally inserted central catheters (PICCs).
  • What is the main objective of the clinical trial? The main objectives are to evaluate the efficacy of REGN7508 compared to placebo for preventing venous thromboembolism (VTE) after PICC placement, and to assess its overall safety and tolerability.
  • Who can participate in this clinical trial? Participants must have a PICC that is expected to remain in place for at least 14 days, have an ECOG Performance Status ≤2, weigh between 50-130 kg, and meet other specific criteria related to blood tests and medical history.
  • How is the drug administered in the trial? REGN7508 is administered as a single intravenous (IV) infusion. The drug comes in the form of a powder for solution for infusion.
  • What are the main outcomes being measured in this trial? The primary outcomes include the incidence of confirmed VTE and the incidence and severity of treatment-emergent adverse events. Secondary outcomes include the incidence of PICC-associated venous thrombosis, major bleeding events, and changes in blood clotting tests.

Ongoing Clinical Trials on Human Igg4 S228P Monoclonal Antibody Against Factor Xi And Activated Factor Xi

  • Comparison of REGN7508 versus apixaban and enoxaparin to prevent blood clots in adults after knee replacement surgery

    Recruiting

    1 1 1
    Investigated drugs:
    Bulgaria Hungary Latvia Lithuania Poland Romania

  • Study on How REGN9933 and REGN7508 Help Prevent Blood Clots in Adults with a Peripherally Inserted Central Catheter (PICC)

    Not recruiting

    1
    Investigated drugs:
    Bulgaria Romania Spain

Glossary

  • Venous Thromboembolism (VTE): A condition where blood clots form in the veins, typically in the legs or arms, which can potentially travel to the lungs causing a pulmonary embolism.
  • Peripherally Inserted Central Catheter (PICC): A long, thin tube inserted through a vein in the arm to deliver medications, fluids, or nutrients directly into the bloodstream near the heart.
  • Monoclonal Antibody: A type of protein made in the laboratory that can bind to specific targets in the body, such as on cancer cells or in the blood. In this case, it targets Factor XI and activated Factor XI.
  • Factor XI: A protein in the blood that plays a role in blood clotting. It is part of the intrinsic pathway of coagulation.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics (PD): The study of how a drug affects the body, including its mechanism of action and relationship between drug concentration and effect.
  • Immunogenicity: The ability of a substance to provoke an immune response in the body, which may affect the drug's effectiveness or safety.
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • International Normalized Ratio (INR): A standardized measurement of how quickly blood clots, often used to monitor the effects of anticoagulant medications.
  • Activated Partial Thromboplastin Time (aPTT): A blood test that measures how long it takes for blood to clot, used to evaluate the intrinsic and common coagulation pathways.

References

  1. http://clinicaltrials.eu/trial/study-on-how-regn9933-and-regn7508-help-prevent-blood-clots-in-adults-with-a-peripherally-inserted-central-catheter-picc/