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NERANDOMILAST

Nerandomilast (also known as BI 1015550) is an investigational drug currently being tested in clinical trials for treating lung fibrosis, particularly in patients with systemic autoimmune rheumatic diseases. These trials aim to determine how effective and safe nerandomilast is in managing interstitial lung diseases (ILDs), a group of disorders that cause scarring of lung tissue. The ongoing studies examine not only the drug’s ability to slow disease progression but also how it interacts with other medications and how its formulation affects its absorption. For patients with lung fibrosis who haven’t responded well to standard treatments, nerandomilast may represent a promising alternative therapy currently under investigation.

Table of Contents

What is Nerandomilast?

Nerandomilast (also known as BI 1015550) is an investigational medication being studied for the treatment of lung fibrosis related to autoimmune rheumatic diseases[1]. It is currently undergoing clinical trials to evaluate its safety and effectiveness. As an investigational drug, it has not yet received full approval from regulatory agencies for widespread use, but the ongoing research aims to determine if it can help patients with specific lung conditions.

What Conditions Does Nerandomilast Treat?

Nerandomilast is being studied primarily for the treatment of Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases (SARD-ILD)[1]. This includes lung fibrosis (scarring) that develops as a complication of rheumatic diseases. Specifically, it is being investigated for:

  • Interstitial Lung Diseases (ILD) – a group of disorders that cause scarring of lung tissue, making breathing difficult
  • Interstitial Lung Disease secondary to Systemic Sclerosis (also known as scleroderma) – where lung scarring occurs as a complication of this autoimmune disease[5]

These conditions typically affect adults and can significantly impact quality of life by causing symptoms like shortness of breath, cough, and fatigue. Nerandomilast is being studied in patients who haven’t shown improvement with standard immunosuppressant treatments[1].

How Nerandomilast Works

While the specific mechanism isn’t fully detailed in the clinical trial information, Nerandomilast appears to target the underlying processes involved in lung fibrosis. The medication is being studied for its potential to:

  • Reduce lung scarring and inflammation
  • Improve lung function in patients with rheumatic disease-related lung conditions
  • Work alongside existing immunosuppressant treatments for the underlying rheumatic disease[1]

The ongoing clinical trials are designed to measure how effectively Nerandomilast can slow or reduce the progression of lung damage compared to placebo (inactive treatment).

How Nerandomilast is Administered

Based on the clinical trial information, Nerandomilast is administered as:

  • Oral tablets taken twice daily[1]
  • Film-coated tablets (in some trials)[5]

In the main clinical study for SARD-ILD, participants take the medication twice daily for 26 weeks (about 6 months)[1]. Different formulations of the tablets are also being tested to determine the best way to administer the medication[4].

Current Clinical Research

Nerandomilast is currently being studied in several clinical trials:

  1. SARD-ILD Study: A double-blind, randomized, placebo-controlled trial evaluating the effectiveness and safety of Nerandomilast over 26 weeks in patients with lung fibrosis related to autoimmune rheumatic diseases. Participants are randomly assigned to receive either Nerandomilast or a placebo while continuing their standard immunosuppressant treatments[1].
  2. Platform Clinical Study for Conquering Scleroderma: A multicenter study evaluating various investigational products, including Nerandomilast, for interstitial lung disease secondary to systemic sclerosis (scleroderma). This study will follow participants for 52 weeks to evaluate changes in lung function[5].
  3. Formulation and Food Effect Studies: Research examining different tablet formulations of Nerandomilast and how food might affect how the body absorbs and processes the medication[4].
  4. Drug Interaction Studies: Investigations into how Nerandomilast interacts with other medications like bosentan and carbamazepine[2][3].

These clinical trials involve various assessments, including lung function tests, chest imaging, and questionnaires about symptoms and quality of life, to determine if Nerandomilast is effective and safe.

Drug Interactions

Researchers are studying how Nerandomilast interacts with other medications. Specific studies include:

  • Bosentan: A study is investigating how bosentan (a moderate Cytochrome P450 3A inducer) affects the pharmacokinetics (how the body processes the drug) of Nerandomilast[2].
  • Carbamazepine: Another study is looking at how carbamazepine might influence the amount of Nerandomilast in the blood[3].

These studies are important because they help researchers understand potential drug interactions that could affect how Nerandomilast works in patients who may be taking multiple medications.

Effects of Food on Nerandomilast

Researchers are also studying whether taking Nerandomilast with or without food affects how the body absorbs and processes the medication. A specific trial is comparing different formulations of Nerandomilast tablets when taken with and without food[4]. This information will help determine the best instructions for patients on when to take the medication in relation to meals.

How Effectiveness is Measured

In the clinical trials, researchers are measuring the effectiveness of Nerandomilast in several ways:

  • Quantitative Interstitial Lung Disease (QILD) score: Measures the extent of lung fibrosis using high-resolution computed tomography (HRCT) scans. This includes measuring:
    • Quantitative Lung Fibrosis (QLF): A measure of reticulation with architectural distortion in the lungs
    • Quantitative Ground Glass Opacity (QGGO): A measure of hazy or cloudy areas within the lung
    A reduction in these scores would indicate improvement[1].
  • Forced Vital Capacity (FVC): A lung function test that measures the amount of air that can be forcibly exhaled after taking a deep breath. Improvements or stabilization in FVC would suggest the medication is helping[1][5].
  • Patient-reported outcomes: Using questionnaires like the Living with Pulmonary Fibrosis (L-PF) to assess symptoms such as:
    • Dyspnea (shortness of breath)
    • Cough
    • Fatigue
    • Quality of life
    Lower scores would indicate symptom improvement[1].
  • Safety assessments: Monitoring for adverse events, including infection-related adverse events[1].

For the scleroderma-specific study, researchers are also looking at the revised CRISS score (Composite Response Index in Systemic Sclerosis) to evaluate overall improvement in participants with diffuse cutaneous systemic sclerosis[5].

Feature Details
Drug Name Nerandomilast (also known as BI 1015550)
Conditions Studied Interstitial Lung Diseases (ILDs), specifically those associated with Systemic Autoimmune Rheumatic Diseases (SARD-ILD)
Target Population Adults 18+ with lung fibrosis related to systemic autoimmune rheumatic disease who show no improvement after standard immunosuppressant treatment
Administration Oral tablets taken twice daily
Main Study Duration 26 weeks (approximately 7.5 months including follow-up)
Primary Outcome Measures Change in quantitative interstitial lung disease (QILD) score measured via high-resolution computed tomography
Secondary Outcome Measures Changes in lung fibrosis patterns (QLF), ground glass opacities (QGGO), forced vital capacity (FVC), symptom scores for breathing and cough, and occurrence of infection-related adverse events
Additional Studies Drug interaction studies with bosentan and carbamazepine; comparison of different formulations; effects of food on drug absorption
Current Status Investigational (in clinical trials)

FAQ

  • What is Nerandomilast and what conditions is it being tested for? Nerandomilast (also known as BI 1015550) is an investigational drug being tested mainly for treating interstitial lung diseases (ILDs), particularly those associated with systemic autoimmune rheumatic diseases. These conditions cause scarring in the lungs that can make breathing difficult. The drug is being studied in patients who haven't shown improvement with standard immunosuppressant treatments.
  • How is Nerandomilast administered in clinical trials? In the clinical trials, Nerandomilast is administered as oral tablets that participants take twice daily. Some studies are comparing different formulations of the drug, and also testing how food might affect how the body absorbs the medication. The typical treatment period in the main efficacy trial lasts for 26 weeks (about 6.5 months).
  • What are researchers measuring to determine if Nerandomilast works? Researchers are primarily measuring changes in lung tissue using quantitative high-resolution computed tomography (qHRCT) to assess the drug's effect on lung fibrosis patterns. They're also measuring lung function through tests like forced vital capacity (FVC), which shows how much air a person can exhale. Additionally, they're tracking symptoms like breathlessness and cough using questionnaires that measure how these symptoms affect quality of life.
  • Are there any interaction studies being conducted with Nerandomilast? Yes, there are specific clinical trials looking at how Nerandomilast interacts with other medications. Studies are examining the effects when Nerandomilast is taken alongside medications like bosentan and carbamazepine. These drug interaction studies help researchers understand if dosage adjustments might be needed when patients take multiple medications together.
  • What is the structure of the clinical trials for Nerandomilast? The main efficacy trial for Nerandomilast is a double-blind, randomized, placebo-controlled study lasting 26 weeks. This means neither the participants nor the researchers know who is receiving the real drug versus placebo during the trial. Participants are randomly assigned to either receive Nerandomilast or a placebo, while continuing their regular immunosuppressant treatments. Other studies examine how the drug interacts with other medications or how different formulations and food affect its absorption in the body.

Ongoing Clinical Trials on NERANDOMILAST

  • Safety, Pharmacokinetics, and Exploratory Efficacy of BI 1015550 and Nerandomilast in Children and Adolescents Aged 2‑17 Years With Fibrosing Interstitial Lung Disease

    Not yet recruiting

    3 1
    Investigated Diseases:
    Investigated Drugs:
    Belgium Czechia Denmark Finland France Germany +6

Glossary

  • Interstitial Lung Disease (ILD): A group of disorders that cause scarring (fibrosis) of lung tissue, making it difficult to breathe and get enough oxygen into the bloodstream.
  • Systemic Autoimmune Rheumatic Diseases (SARD): A group of conditions where the immune system attacks the body's own tissues, affecting multiple organ systems including joints, skin, and internal organs like the lungs.
  • Placebo: A substance that looks like medicine but contains no active medication. Used in clinical trials to help determine if the effects of a new treatment are due to the treatment itself or other factors.
  • Double-blind: A research method where neither the participants nor the researchers know who is receiving the real treatment versus placebo until after the trial is completed.
  • Randomized: The process of assigning participants to different treatment groups by chance, which helps reduce bias in research studies.
  • Forced Vital Capacity (FVC): A measurement of lung function that shows the total amount of air a person can forcefully exhale after taking the deepest breath possible.
  • Quantitative Interstitial Lung Disease (QILD) score: A measurement obtained from lung scans that quantifies the extent of lung damage, expressed as a percentage of affected lung tissue.
  • Quantitative Lung Fibrosis (QLF): A measure of reticulation with architectural distortion in the lungs, indicating the extent of fibrotic tissue.
  • Ground Glass Opacity (GGO): Hazy or cloudy areas visible on lung scans that indicate partial filling of air spaces in the lungs, often seen in interstitial lung diseases.
  • Pharmacokinetics: The study of how drugs move through the body, including how they're absorbed, distributed, metabolized, and eliminated.
  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and so is able to have an active effect.
  • Immunosuppressant: Medications that decrease the activity of the immune system, often used to treat autoimmune diseases.
  • AUC (Area Under the Curve): A measurement used in drug studies to show the total exposure to a drug over time.
  • Cmax: The maximum concentration of a drug in the blood after it has been administered.
  • Cytochrome P450 (CYP3A): A family of enzymes involved in drug metabolism in the body that can be affected by some medications, potentially altering how other drugs are processed.
  • Dyspnea: Shortness of breath or difficulty breathing, a common symptom in lung diseases.
  • High-Resolution Computed Tomography (HRCT): A specialized imaging technique that provides detailed pictures of the lungs and can detect subtle changes in lung tissue.

References

  1. https://clinicaltrials.gov/study/NCT06806592
  2. https://clinicaltrials.gov/study/NCT07081932
  3. https://clinicaltrials.gov/study/NCT07100964
  4. https://clinicaltrials.gov/study/NCT06624072
  5. https://clinicaltrials.eu/trial/study-of-amlitelimab-and-bi-1015550-for-patients-with-interstitial-lung-disease-due-to-scleroderma/