An NIH Trial of Severe Asthma Treatment Tailored to Suptypes

Repurposing Gleevec as an asthma drug is one of the avenues being explored in the PrecISE severe asthma study. The study has an adaptive design.

Although severe asthma accounts for only 3% to 10% of the adult population with asthma, it accounts for more than half of asthma-related healthcare expenditures. Part of that cost includes the development of new and effective treatments.

People with severe asthma have symptoms that are difficult to control and are prone to frequent asthma exacerbations. In addition, symptom triggers and response to treatment may vary depending on the presence of biomarkers such as immunoglobulin (IgE), eosinophils, and neutrophils. Because of this variability, patients with severe asthma are divided into different subtypes. Developing treatments that target a specific pathology can be challenging.

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The National Heart, Lung, and Blood Institute is funding a study designed to match individual patients with severe asthma to treatments that specifically target the underlying pathology of their disease subtype. The Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network (PrecISE) study began in 2019 and is expected to complete in June 2023. This study is designed to use adaptive design and precision medicine to assign severe asthma subgroups to treatment arms targeting the mechanisms of each asthma subtype. A key objective of the study is to identify novel treatments for patients with severe asthma that are effective in their biomarker-based subset.

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Study interventions include clazakizumab, an interleukin-6 inhibitor, to combat systemic inflammation that can worsen asthma. Gleevec (imatinib), a kinase inhibitor used as a cancer drug that may be repurposed for asthma because it has been shown to reduce mast cells in the airways. Covosonstat helps increase levels of S-nitrosoglutathione (GSNO), an endogenous bronchodilator. A dietary supplement that affects energy breakdown and another that provides lyophilisates of respiratory bacteria form the last two arms of the study.

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Each intervention will last four months, and researchers will be able to quickly assess each group’s response to treatment while examining multiple interventions simultaneously. The PrecISE trial is currently in Phase 2. Treatments shown to be effective in this phase could advance to larger Phase 3 trials.

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