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Human Igg1 Monoclonal Antibody Against Human Il-1 Beta And Human Il-18

Recent clinical trials are investigating the potential of a novel drug called MAS825, a human IgG1 monoclonal antibody that targets both IL-1 beta and IL-18. This innovative treatment is being studied for its efficacy in managing autoinflammatory diseases and reducing inflammation in patients with coronary heart disease and clonal hematopoiesis. The trials aim to evaluate the drug’s safety, tolerability, and effectiveness in improving patient outcomes across different medical conditions.

Table of Contents

What is MAS825?

MAS825 is a new medication being developed to treat certain rare and complex diseases. It is classified as a human IgG1 monoclonal antibody, which means it’s a type of protein designed to target specific parts of the immune system[1]. Specifically, MAS825 works against two important immune system molecules: IL-1 beta and IL-18. These molecules are involved in inflammation, which is a key factor in many diseases.

Targeted Conditions

MAS825 is being studied for its potential to treat several rare conditions, including:

  • NLRC4-Gain of Function (GOF): Also known as autoinflammation with infantile enterocolitis (AIFEC), this is a genetic condition that causes severe inflammation in the intestines, often starting in infancy[1].
  • X-linked Inhibitor of Apoptosis Protein (XIAP) deficiency: A rare genetic disorder affecting the immune system and causing inflammation[1].
  • Cell division control protein 42 homolog (CDC42) mutations: Genetic changes that can lead to various health problems, including inflammation[1].

Additionally, MAS825 is being investigated for its potential in treating atherosclerotic cardiovascular disease in patients with a condition called Clonal Hematopoiesis of Indeterminate Potential (CHIP)[2]. This research aims to see if MAS825 can help reduce inflammation in people with heart disease and certain genetic changes in their blood cells.

How MAS825 Works

MAS825 is designed to target and block the actions of IL-1 beta and IL-18, two proteins that play a significant role in inflammation. By inhibiting these proteins, MAS825 aims to reduce inflammation in the body, potentially alleviating symptoms and improving the overall health of patients with autoinflammatory diseases or certain cardiovascular conditions[1][2].

Clinical Trials

MAS825 is currently being studied in clinical trials to evaluate its effectiveness and safety. Two main studies are underway:

  1. A study focusing on patients with autoinflammatory diseases, including NLRC4-GOF, XIAP deficiency, and CDC42 mutations. This trial aims to determine if MAS825 can prevent disease flares and improve patients’ overall condition[1].
  2. A study investigating the use of MAS825 in adults with coronary heart disease and CHIP. This trial is looking at whether MAS825 can reduce inflammation markers in these patients[2].

Potential Benefits

Based on the ongoing clinical trials, MAS825 may offer several potential benefits:

  • Prevention of disease flares in autoinflammatory conditions[1]
  • Improvement in clinical status and reduction of symptoms[1]
  • Reduction in the need for glucocorticoid therapy (a type of steroid medication)[1]
  • Reduction of inflammation markers in patients with heart disease and CHIP[2]

Administration

MAS825 is administered in two ways, depending on the condition being treated:

  • As a solution for injection, likely given intravenously (into a vein)[1]
  • As a subcutaneous injection (under the skin)[2]

The dosage and frequency of administration may vary based on the specific condition and individual patient factors.

Safety and Side Effects

As MAS825 is still in clinical trials, its full safety profile is not yet established. The ongoing studies are carefully monitoring for any adverse events or side effects. Patients considering participation in MAS825 trials should discuss potential risks with their healthcare providers[1][2].

Eligibility for Treatment

Eligibility for MAS825 treatment in clinical trials varies depending on the specific study. Generally, patients must:

  • Have a confirmed genetic diagnosis of the targeted conditions (for the autoinflammatory disease study)[1]
  • Meet specific age and weight requirements[1][2]
  • Not have certain other medical conditions or infections[1][2]
  • For the cardiovascular study, have a history of heart attack and confirmed CHIP[2]

Future Prospects

MAS825 represents a promising new approach to treating complex inflammatory conditions and certain cardiovascular diseases. As research continues, it may offer hope for patients with conditions that currently have limited treatment options. However, it’s important to remember that MAS825 is still in the testing phase, and more studies are needed to fully understand its effectiveness and safety profile[1][2].

Aspect Trial 2023-504419-34-00 Trial 2023-506741-34-00
Primary Objective Determine efficacy of MAS825 in preventing flares in autoinflammatory diseases Evaluate effect of MAS825 on reducing inflammatory markers in coronary heart disease and CHIP
Target Population Patients with NLRC4-GOF, XIAP deficiency, or CDC42 mutations Adults with coronary heart disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP)
Administration Route Intravenous use Subcutaneous use
Primary Endpoints Occurrence of disease flare assessed by Physician’s Global Assessment and inflammatory markers Serum levels of IL-6 and IL-18 at 3 weeks after treatment
Key Secondary Objectives Evaluate safety, tolerability, serological markers, and effect on glucocorticoid use Assess safety, tolerability, and pharmacokinetics of MAS825

FAQ

  • What is MAS825 and how does it work? MAS825 is a human IgG1 monoclonal antibody that targets both IL-1 beta and IL-18. These are inflammatory molecules in the body. By blocking these molecules, MAS825 aims to reduce inflammation in various diseases.
  • What conditions are being studied with MAS825? MAS825 is being studied for autoinflammatory diseases, including NLRC4-GOF (also known as AIFEC), XIAP deficiency, and CDC42 mutations. It's also being investigated for reducing inflammation in patients with coronary heart disease and clonal hematopoiesis.
  • How is MAS825 administered to patients? MAS825 can be administered in different ways depending on the study. In one trial, it's given as a solution for injection intravenously. In another study, it's administered subcutaneously (under the skin).
  • What are the main goals of these clinical trials? The main goals include evaluating the efficacy of MAS825 in preventing disease flares, assessing its safety and tolerability, measuring its effect on inflammatory markers, and determining its ability to improve patients' clinical status and quality of life.
  • Who can participate in these clinical trials? Eligibility varies by study. Generally, patients with specific genetic diagnoses or conditions are included. For example, one study focuses on patients with NLRC4-GOF, XIAP deficiency, or CDC42 mutations. Another includes adults with coronary heart disease and clonal hematopoiesis. Specific age ranges and other criteria apply.

Ongoing Clinical Trials on Human Igg1 Monoclonal Antibody Against Human Il-1 Beta And Human Il-18

  • A Study of MAS825 in Children and Adults with Still’s Disease to Test How Well It Works and How Safe It Is

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Spain

  • Study on DFV890 and MAS825 for Reducing Inflammation in Adults with Coronary Heart Disease and Clonal Hematopoiesis

    Not recruiting

    2 1
    Investigated drugs:
    Germany

  • Study on MAS825 for Patients with Monogenic IL-18 Driven Autoinflammatory Diseases, Including NLRC4-GOF, XIAP Deficiency, or CDC42 Mutations

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Italy Spain

Glossary

  • Monoclonal Antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. In this case, MAS825 is a monoclonal antibody designed to target specific inflammatory molecules.
  • IL-1 beta and IL-18: These are interleukins, which are types of cytokines (signaling molecules) involved in the immune response and inflammation process in the body.
  • Autoinflammatory Diseases: A group of disorders characterized by seemingly unprovoked inflammation, often due to problems with the innate immune system.
  • NLRC4-GOF: A genetic condition also known as Autoinflammation with Infantile Enterocolitis (AIFEC), caused by a gain-of-function mutation in the NLRC4 gene.
  • XIAP Deficiency: A rare genetic disorder affecting the immune system, caused by mutations in the XIAP gene.
  • CDC42 Mutation: A genetic alteration in the CDC42 gene, which can lead to various health issues including some forms of autoinflammatory disease.
  • Clonal Hematopoiesis: A condition where a genetic mutation gives a stem cell a competitive advantage, leading to a disproportionate number of blood cells with that mutation.
  • Coronary Heart Disease: A type of heart disease where the coronary arteries become narrowed or blocked, often due to atherosclerosis.
  • Inflammatory Markers: Substances in the blood that indicate the presence of inflammation in the body, such as C-reactive protein (CRP) or certain interleukins.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.

References

  1. http://clinicaltrials.eu/trial/study-on-mas825-for-patients-with-monogenic-il-18-driven-autoinflammatory-diseases-including-nlrc4-gof-xiap-deficiency-or-cdc42-mutations/
  2. http://clinicaltrials.eu/trial/study-on-dfv890-and-mas825-for-reducing-inflammation-in-adults-with-coronary-heart-disease-and-clonal-hematopoiesis/