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1-[[(5R)-2-[4-(5-Chloro-2-Pyrimidinyl)-1-Piperidinyl]-6,7- Dihydro-5-Oxidothieno[3,2-D]Pyrimidin-4- Yl]Amino]-Cyclobutanemethanol

This article explores the ongoing clinical trials of BI 1015550, a novel drug being investigated for the treatment of pulmonary fibrosis, particularly idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). These trials aim to assess the safety, efficacy, and long-term effects of BI 1015550 in patients with various forms of pulmonary fibrosis. The studies range from Phase I to Phase III trials, evaluating different aspects of the drug’s performance and its potential to improve lung function and quality of life for patients with these challenging respiratory conditions.

Table of Contents

Introduction

BI 1015550, also known as nerandomilast, is an innovative medication currently being studied for the treatment of various forms of pulmonary fibrosis. This article will provide an overview of this promising new drug, its potential benefits, and the ongoing research to evaluate its effectiveness and safety.[1][2][3]

What is BI 1015550?

BI 1015550 is a novel drug developed by Boehringer Ingelheim. Its chemical name is 1-[[(5R)-2-[4-(5-chloro-2-pyrimidinyl)-1-piperidinyl]-6,7-dihydro-5-oxidothieno[3,2-d]pyrimidin-4-yl]amino]-cyclobutanemethanol. This complex name describes the unique molecular structure of the drug, which is designed to target specific processes involved in pulmonary fibrosis.[1]

What Conditions Does BI 1015550 Treat?

BI 1015550 is being investigated for the treatment of several lung conditions, including:

  • Idiopathic Pulmonary Fibrosis (IPF): A chronic lung disease that causes scarring (fibrosis) of the lungs for unknown reasons.
  • Progressive Pulmonary Fibrosis (PPF): A group of lung diseases characterized by worsening fibrosis over time.
  • Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs): A broader category of lung diseases that involve progressive scarring of lung tissue.

These conditions all involve the gradual buildup of scar tissue in the lungs, which can make breathing increasingly difficult over time.[1][3]

How Does BI 1015550 Work?

While the exact mechanism of action is not fully described in the provided information, BI 1015550 is designed to target the processes that lead to lung fibrosis. By potentially slowing down or stopping the formation of scar tissue in the lungs, this medication aims to preserve lung function and improve the quality of life for patients with pulmonary fibrosis.[3]

Clinical Trials and Research

Several clinical trials are currently underway to evaluate the safety and efficacy of BI 1015550:

  1. FIBRONEER-ON Study: This is a long-term extension trial to assess the safety and efficacy of BI 1015550 in patients with IPF and PPF who have completed previous studies with the drug.[1]
  2. Bioavailability Study: This trial compares two different formulations of BI 1015550 (also called nerandomilast) and investigates how food affects the absorption of the drug.[2]
  3. FIBRONEER-ILD Study: This is a larger trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs).[3]

The main goals of these studies include:

  • Assessing the long-term safety and tolerability of BI 1015550
  • Measuring the drug’s effect on lung function, particularly the Forced Vital Capacity (FVC), which is the amount of air a person can forcefully exhale after taking a deep breath
  • Evaluating the impact on disease progression, including the time to acute exacerbations, hospitalizations, or death
  • Investigating the drug’s effects on patient-reported symptoms such as breathlessness, cough, and fatigue

How is BI 1015550 Administered?

BI 1015550 is administered orally as a film-coated tablet. The exact dosage and frequency may vary depending on the specific clinical trial or treatment protocol. In some studies, the maximum daily dose is reported as 18 mg.[1][3]

Potential Side Effects

As with any medication, BI 1015550 may cause side effects. The ongoing clinical trials are designed to carefully monitor and assess any adverse events that may occur. Some areas of particular interest include:

  • Liver function: Patients with elevated liver enzymes (AST or ALT > 2.5 times the upper limit of normal) are typically excluded from the trials.[3]
  • Mental health: Patients with severe depression or suicidal thoughts are carefully screened before participation.[1]
  • Infections: The impact on the risk of infections is being monitored.[3]

It’s important to note that the full safety profile of BI 1015550 is still being established through these clinical trials.

Conclusion

BI 1015550 (nerandomilast) represents a promising new approach in the treatment of pulmonary fibrosis. While still in the research phase, this medication has the potential to offer new hope for patients with progressive lung diseases. As clinical trials continue, more information will become available about its effectiveness and safety profile. Patients interested in learning more about BI 1015550 should consult with their healthcare providers and consider the possibility of participating in clinical trials if appropriate.

Aspect Details
Drug Name BI 1015550 (also known as nerandomilast)
Target Conditions Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis (PPF)
Trial Phases Phase I to Phase III
Administration Oral, film-coated tablet
Primary Objectives Assess long-term safety and efficacy, reduce lung function decline
Key Endpoints Changes in FVC, time to acute exacerbations, hospitalizations, or death
Eligibility Adults with IPF or PPF, specific lung function criteria
Trial Designs Open-label extension, randomized placebo-controlled, bioavailability studies

FAQ

  • What is BI 1015550? BI 1015550, also known as nerandomilast, is a new drug being tested for the treatment of pulmonary fibrosis, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). It is taken orally as a film-coated tablet.
  • What are the main objectives of the clinical trials for BI 1015550? The main objectives of the clinical trials are to assess the long-term safety and efficacy of BI 1015550, evaluate its ability to reduce lung function decline, and investigate its effects on reducing clinically meaningful events such as acute exacerbations, hospitalizations, and death in patients with pulmonary fibrosis.
  • Who can participate in these clinical trials? Eligibility varies depending on the specific trial, but generally includes adults (18 years or older) with a diagnosis of IPF or PPF. Some trials require participants to have specific lung function measurements, such as Forced Vital Capacity (FVC) ≥45% of predicted normal and Diffusing Capacity for Carbon Monoxide (DLCO) ≥25% of predicted normal.
  • How is the effectiveness of BI 1015550 being measured in these trials? The effectiveness of BI 1015550 is being measured through various endpoints, including changes in lung function tests (such as FVC and DLCO), time to acute exacerbations or hospitalizations, and patient-reported outcomes using questionnaires like the Living with Pulmonary Fibrosis (L-PF) Symptoms scale.
  • Are there any side effects or risks associated with BI 1015550? As with any clinical trial, there may be potential risks and side effects. The trials are designed to monitor and assess any adverse events closely. Specific side effects are not mentioned in the provided information, as one of the main objectives of these trials is to evaluate the safety profile of BI 1015550.

Ongoing Clinical Trials on 1-[[(5R)-2-[4-(5-Chloro-2-Pyrimidinyl)-1-Piperidinyl]-6,7- Dihydro-5-Oxidothieno[3,2-D]Pyrimidin-4- Yl]Amino]-Cyclobutanemethanol

  • A study to evaluate the effectiveness of BI 1015550 in people with lung abnormalities and a family history of pulmonary fibrosis

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Spain

  • Study to Test if Nerandomilast (BI 1015550) Helps Patients with Interstitial Lung Disease Related to Rheumatic Diseases

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Austria France Germany Italy The Netherlands Norway +1

  • Long-Term Study of BI 1015550 for Patients with Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Croatia Czechia Denmark Estonia +14

  • Study on BI 1015550 for Improving Lung Function in Patients with Progressive Fibrosing Interstitial Lung Diseases

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Croatia Czechia Denmark Estonia +13

Glossary

  • Idiopathic Pulmonary Fibrosis (IPF): A chronic lung disease characterized by progressive scarring (fibrosis) of the lungs, causing breathing difficulties. The term 'idiopathic' means the cause is unknown.
  • Progressive Pulmonary Fibrosis (PPF): A group of lung diseases that involve progressive scarring of the lungs, leading to worsening breathing difficulties over time.
  • Forced Vital Capacity (FVC): The total amount of air exhaled during a forced breath, which is an important measure of lung function used to assess the progression of pulmonary fibrosis.
  • Diffusing Capacity for Carbon Monoxide (DLCO): A test that measures how well oxygen moves from the lungs into the blood, often used to evaluate the severity of lung diseases like pulmonary fibrosis.
  • Acute Exacerbation: A sudden worsening of symptoms in chronic lung diseases, which can be life-threatening and often requires hospitalization.
  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and is able to have an active effect.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Film-Coated Tablet: A type of oral medication where the tablet is coated with a thin layer to make it easier to swallow or to control how it releases the drug in the body.
  • Open-Label Extension Trial: A type of clinical trial where participants and researchers know which treatment is being given, often following a completed randomized controlled trial to gather long-term data.
  • Placebo-Controlled Trial: A clinical trial where some participants receive an inactive substance (placebo) instead of the active drug, used to compare the effects of the drug against no treatment.

References

  1. http://clinicaltrials.eu/trial/long-term-study-of-bi-1015550-for-patients-with-idiopathic-pulmonary-fibrosis-and-progressive-pulmonary-fibrosis/
  2. http://clinicaltrials.eu/trial-id/2024-511245-18-00
  3. http://clinicaltrials.eu/trial/study-on-bi-1015550-for-improving-lung-function-in-patients-with-progressive-fibrosing-interstitial-lung-diseases/