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Dexpramipexole Dihydrochloride Monohydrate

This article explores the use of Dexpramipexole Dihydrochloride Monohydrate in clinical trials for treating eosinophilic asthma. Multiple phase III studies are examining the efficacy, safety, and tolerability of this drug in adolescents and adults with severe eosinophilic asthma. The trials aim to evaluate its effects on reducing asthma exacerbations, improving lung function, asthma control, and quality of life, as well as its impact on blood eosinophil levels.

Table of Contents

What is Dexpramipexole?

Dexpramipexole is an investigational drug being studied for the treatment of severe eosinophilic asthma. It is also known by its chemical name dexpramipexole dihydrochloride monohydrate and the code name KNS-760704.[1] This medication is being developed by Areteia Therapeutics and is currently in Phase III clinical trials.[1]

Mechanism of Action

While the exact mechanism of action is not fully described in the provided clinical trial information, dexpramipexole is believed to work by reducing the number of eosinophils in the blood. Eosinophils are a type of white blood cell that can contribute to inflammation in the airways of people with asthma. By lowering eosinophil levels, dexpramipexole may help reduce asthma symptoms and exacerbations in patients with eosinophilic asthma.[1]

Clinical Trials

Several Phase III clinical trials are currently underway to evaluate the efficacy and safety of dexpramipexole in patients with severe eosinophilic asthma:

  • EXHALE-2 and EXHALE-3: 52-week studies comparing dexpramipexole to placebo[1]
  • EXHALE-4: A 24-week study evaluating dexpramipexole’s effects on lung function[2]
  • EXHALE-5: A long-term extension study assessing the safety and efficacy of dexpramipexole over an extended period[3]

Efficacy

The primary goals of the clinical trials are to assess dexpramipexole’s ability to:

  • Reduce the rate of severe asthma exacerbations[1]
  • Improve lung function (measured by FEV1, or forced expiratory volume in 1 second)[1]
  • Enhance asthma control and quality of life[1]
  • Lower blood eosinophil counts[1]

Results from these trials are not yet available, as the studies are ongoing.

Safety and Side Effects

The safety profile of dexpramipexole is still being evaluated in the ongoing clinical trials. Some potential areas of concern that are being monitored include:

  • Effects on heart rhythm (QT interval prolongation)[1]
  • Liver function[1]
  • Kidney function[1]
  • Neutrophil counts (a type of white blood cell)[1]

Patients with a history of certain medical conditions, such as heart problems, liver disease, or kidney disease, may be excluded from the trials due to potential safety concerns.

Administration

Dexpramipexole is being studied as an oral medication in the form of film-coated tablets. In the clinical trials, it is being tested at doses of 75 mg and 150 mg, taken twice daily.[1] The medication is intended to be taken in addition to patients’ standard asthma treatments, such as inhaled corticosteroids and other controller medications.

Patient Population

Dexpramipexole is being studied in patients with severe eosinophilic asthma. Key characteristics of the target patient population include:

  • Age 12 years and older (18 and older in some countries)[1]
  • Diagnosis of asthma for at least 12 months[1]
  • Elevated blood eosinophil levels (≥0.30 x 10^9/L)[1]
  • Inadequate asthma control despite treatment with medium to high-dose inhaled corticosteroids and additional controller medications[1]
  • History of asthma exacerbations requiring systemic corticosteroids[1]

Future Research

As the Phase III clinical trials for dexpramipexole are ongoing, future research will focus on analyzing the results of these studies to determine the drug’s efficacy and safety profile. If the results are positive, the next steps may include:

  • Submitting applications for regulatory approval
  • Conducting additional studies to evaluate long-term safety and efficacy
  • Investigating the drug’s potential in other eosinophilic conditions

It’s important to note that dexpramipexole is still an investigational drug and is not currently approved for use outside of clinical trials. Patients with severe eosinophilic asthma should consult with their healthcare providers about currently available treatment options and the possibility of participating in clinical trials.

Aspect Details
Drug Name Dexpramipexole Dihydrochloride Monohydrate
Condition Studied Severe Eosinophilic Asthma
Trial Phase Phase III
Administration Oral, film-coated tablets
Dosages Studied 75 mg and 150 mg twice daily
Primary Endpoints Reduction in severe asthma exacerbations, improvement in lung function (FEV1)
Secondary Endpoints Asthma control (ACQ-6), quality of life (AQLQ+12), blood eosinophil levels
Study Duration 24 to 52 weeks, with a long-term extension study
Key Inclusion Criteria Age ≥12 years, diagnosed asthma for ≥12 months, on medium/high dose ICS, blood eosinophil count ≥0.30×10^9/L
Key Exclusion Criteria Recent severe exacerbation, smoking history, certain cardiovascular conditions, renal or liver dysfunction

FAQ

  • What is Dexpramipexole Dihydrochloride Monohydrate? Dexpramipexole Dihydrochloride Monohydrate is an investigational drug being studied for the treatment of severe eosinophilic asthma. It is taken orally in the form of film-coated tablets.
  • What is the main goal of these clinical trials? The main goals of these trials are to assess the efficacy, safety, and tolerability of Dexpramipexole in reducing severe asthma exacerbations, improving lung function, asthma control, and quality of life in patients with severe eosinophilic asthma.
  • Who can participate in these trials? Generally, these trials include male and female participants aged 12 years and older (18 and older in some countries) with a documented diagnosis of severe eosinophilic asthma for at least 12 months. Specific eligibility criteria vary between studies.
  • How long do these clinical trials last? The duration of the trials varies. Some studies last for 24 weeks, while others continue for 52 weeks. There is also a long-term extension study (EXHALE-5) to assess the long-term safety and efficacy of the drug.
  • What are the main outcomes being measured in these trials? The main outcomes include the rate of severe asthma exacerbations, changes in lung function (measured by FEV1), improvements in asthma control and quality of life (measured by questionnaires like ACQ-6 and AQLQ+12), and changes in blood eosinophil levels.

Ongoing Clinical Trials on Dexpramipexole Dihydrochloride Monohydrate

  • Study on the Effects of Dexpramipexole for Adolescents and Adults with Severe Eosinophilic Asthma

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Poland Romania

  • Study on the Effects of Dexpramipexole for Adolescents and Adults with Severe Eosinophilic Asthma

    Not recruiting

    1 1 1
    Investigated drugs:
    Austria Croatia Czechia France Germany Hungary +3

  • Study on the Effects of Dexpramipexole in Adolescents and Adults with Eosinophilic Asthma

    Not recruiting

    1 1
    Investigated drugs:
    Poland Romania

  • Long-term safety study of dexpramipexole tablets in patients with severe eosinophilic asthma who completed EXHALE-2 or EXHALE-3 trials

    Not recruiting

    1 1 1
    Investigated drugs:
    Bulgaria Czechia Germany Italy Poland Romania +1

Glossary

  • Eosinophilic asthma: A type of severe asthma characterized by high levels of eosinophils (a type of white blood cell) in the blood and airways, which contribute to inflammation and asthma symptoms.
  • FEV1: Forced Expiratory Volume in 1 second, a measure of lung function that represents the amount of air a person can forcefully exhale in one second.
  • ACQ-6: Asthma Control Questionnaire-6, a standardized tool used to assess asthma control in patients.
  • AQLQ+12: Asthma Quality of Life Questionnaire for 12 years and older, a tool used to measure the impact of asthma on a person's quality of life.
  • Bronchodilator reversibility: A test to measure how much lung function improves after taking a fast-acting inhaled bronchodilator medication.
  • Exacerbation: A worsening of asthma symptoms that requires additional treatment, such as oral corticosteroids, emergency care, or hospitalization.
  • Inhaled corticosteroids (ICS): A type of anti-inflammatory medication inhaled directly into the lungs to reduce airway inflammation in asthma patients.
  • Long-acting β2 agonist (LABA): A type of bronchodilator medication that helps to relax and open the airways, typically used in combination with inhaled corticosteroids for asthma control.
  • Monoclonal antibody therapy: A type of targeted treatment that uses antibodies designed to block specific molecules involved in the inflammatory process of asthma.
  • QTcF interval: The corrected QT interval using Fridericia's formula, which is a measure of the heart's electrical cycle used to assess the risk of certain heart rhythm abnormalities.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-dexpramipexole-for-adolescents-and-adults-with-severe-eosinophilic-asthma-3/
  2. http://clinicaltrials.eu/trial/study-on-the-effects-of-dexpramipexole-in-adolescents-and-adults-with-eosinophilic-asthma/
  3. http://clinicaltrials.eu/trial/study-on-the-long-term-safety-of-dexpramipexole-for-patients-with-severe-eosinophilic-asthma/