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Int-787

A new clinical trial is underway to assess the potential of INT-787, a novel drug designed to treat severe alcohol-associated hepatitis (sAH). This Phase 2a study aims to determine the safety, effectiveness, and optimal dosage of INT-787 in patients with this serious liver condition. The trial will compare INT-787 to a placebo, providing valuable insights into its potential as a treatment option for those suffering from sAH.

Table of Contents

What is INT-787?

INT-787 is a new drug being studied for the treatment of severe alcohol-associated hepatitis (sAH). It is currently undergoing a Phase 2a clinical trial, which means it’s in the early stages of testing in humans to determine its safety and effectiveness[1]. This drug is being developed as a potential new treatment option for patients with this serious liver condition.

What Condition Does INT-787 Treat?

INT-787 is specifically being studied to treat severe alcohol-associated hepatitis (sAH). This is a serious form of liver damage caused by excessive alcohol consumption. In sAH, the liver becomes inflamed and damaged, leading to various health complications. It’s a life-threatening condition that currently has limited treatment options, making the development of new drugs like INT-787 crucial[1].

Details of the FRESH Study

The clinical trial for INT-787 is called the FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study. Here are some key details about the study:

  • Type of study: It’s a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-escalation, proof-of-concept study. This means:
    • It’s an early-phase study to test the drug’s effectiveness and safety.
    • Participants are randomly assigned to either receive INT-787 or a placebo (a substance with no active ingredients).
    • Neither the participants nor the researchers know who is receiving the actual drug or the placebo (this is what “double-blind” means).
    • The study is being conducted at multiple medical centers.
    • Different doses of the drug will be tested to find the most effective and safe dose.
  • Purpose: The study aims to assess the safety, tolerability, effectiveness, and how the body processes INT-787 (known as pharmacokinetics) in patients with severe alcohol-associated hepatitis[1].

How INT-787 Works

While the exact mechanism of INT-787 is not detailed in the provided information, we can infer some details based on the study name. The “FXR” in the study title likely refers to the Farnesoid X Receptor, which is an important regulator in the liver. FXR activation has been shown to have beneficial effects on liver health, including reducing inflammation and fibrosis (scarring of the liver). INT-787 may work by targeting this receptor to improve liver function in patients with severe alcohol-associated hepatitis[1].

Expected Benefits of INT-787

The researchers are looking at several ways to measure if INT-787 is effective:

  1. Lille model response: This is a scoring system used to predict the outcome of patients with severe alcoholic hepatitis. A lower score (less than 0.45) indicates a better response to treatment[1].
  2. Change in MELD score: The Model for End-Stage Liver Disease (MELD) score is used to assess the severity of liver disease. A decrease in this score would indicate improvement in liver function[1].
  3. Change in total bilirubin: Bilirubin is a substance produced when the liver breaks down old red blood cells. High levels can indicate liver problems, so a decrease would be a positive sign[1].
  4. Mortality or liver transplantation rates: The study will look at whether INT-787 can reduce the number of deaths or need for liver transplants compared to placebo[1].

Safety Monitoring

The safety of INT-787 is a crucial aspect of the study. The researchers will be closely monitoring:

  • Treatment emergent adverse events (TEAEs): Any new medical problems that occur during the study.
  • Serious adverse events (SAEs): Any severe medical issues that arise.
  • Adverse events of special interest (AESIs): Specific medical issues that the researchers are particularly watching for.
  • Infectious adverse events: Any infections that occur during the study[1].

Future Implications

If INT-787 proves to be safe and effective in this study, it could potentially become a new treatment option for patients with severe alcohol-associated hepatitis. This would be a significant development, as current treatment options for this condition are limited. The study will also provide valuable information about how the drug behaves in the body of patients with advanced liver disease, which will be crucial for planning future clinical trials[1].

Aspect Details
Study Type Phase 2a, randomized, double-blind, placebo-controlled, dose-escalation
Drug INT-787
Condition Severe Alcohol-Associated Hepatitis (sAH)
Primary Outcome Lille model response based on Lille score
Key Secondary Outcomes Change in MELD score, change in total bilirubin, mortality/transplantation rates
Safety Measures Monitoring of TEAEs, SAEs, AESIs, and infectious adverse events
Pharmacokinetic Measures Total exposure (AUC), Maximum Plasma Concentration (Cmax), Elimination half-life

FAQ

  • What is the purpose of this clinical trial? The main purpose of this trial is to assess the safety, effectiveness, and optimal dosage of INT-787 in patients with severe alcohol-associated hepatitis (sAH). It aims to provide a rationale for selecting the best dose(s) of INT-787 for future treatments.
  • How is the trial designed? This is a Phase 2a, randomized, double-blind, placebo-controlled study. It involves dose escalation, which means different groups of patients will receive increasing doses of INT-787 or a placebo. The trial will evaluate how well patients tolerate the drug and how effective it is compared to the placebo.
  • What is severe alcohol-associated hepatitis (sAH)? Severe alcohol-associated hepatitis (sAH) is a serious liver condition caused by excessive alcohol consumption. It leads to inflammation and damage in the liver, which can result in liver failure if left untreated.
  • How will the effectiveness of INT-787 be measured? The main measure of effectiveness will be the Lille score response rate. Other measures include changes in the Model for End-Stage Liver Disease (MELD) score, changes in total bilirubin levels, and differences in mortality or liver transplantation rates between INT-787 and placebo groups.
  • What safety measures are in place for this trial? The trial will closely monitor for any treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs). It will also specifically track infectious adverse events. These safety measures help ensure the well-being of participants throughout the study.

Ongoing Clinical Trials on Int-787

  • Study on the Effects of INT-787 for Patients with Severe Alcohol-Associated Hepatitis

    Not recruiting

    1
    Investigated drugs:
    France

Glossary

  • Alcohol-Associated Hepatitis (AH): A liver disease caused by excessive alcohol consumption, leading to inflammation and damage in the liver.
  • Phase 2a Trial: An early stage of clinical research that tests a drug's effectiveness and safety in a small group of patients with the target condition.
  • Randomized: A method of assigning participants to different treatment groups by chance, reducing bias in the study.
  • Double-Blind: A study design where neither the participants nor the researchers know who is receiving the actual drug or the placebo.
  • Placebo-Controlled: A study that compares the effects of a drug to those of an inactive substance (placebo) to determine the drug's true impact.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Lille Score: A medical scoring system used to predict survival in patients with alcoholic hepatitis. A score below 0.45 indicates a positive response to treatment.
  • Model for End-Stage Liver Disease (MELD) Score: A scoring system used to assess the severity of chronic liver disease, ranging from 6 to 40, with higher scores indicating more severe disease.
  • International Normalized Ratio (INR): A standardized measurement of blood clotting time, often used to assess liver function.
  • Treatment Emergent Adverse Events (TEAEs): Any unfavorable medical occurrence that appears or worsens after starting a medical treatment.
  • Serious Adverse Events (SAEs): Any adverse event that results in death, is life-threatening, requires hospitalization, or causes significant disability.
  • Adverse Events of Special Interest (AESIs): Specific adverse events that are closely monitored in a clinical trial due to their potential significance.
  • System Organ Class (SOC): A way of grouping adverse events by the body system they affect, used in medical reporting.
  • Area Under the Curve (AUC): A measure of the total exposure to a drug over time, used in pharmacokinetic studies.
  • Maximum Plasma Concentration (Cmax): The highest concentration of a drug in the blood plasma after administration.
  • Elimination Half-Life: The time it takes for half of a drug to be eliminated from the body.

References