Innovative oral therapy to improve lung function in selected moderate to severe asthma patients announced the latest phase 2 trial results

On September 7, 2021, Knopp Biosciences announced the further clinical and biomarker data of dexpramipexole, a phase 2 clinical trial of EXHALE in patients with moderate to severe eosinophilic asthma
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Test data showed that the decrease in eosinophil count caused by oral administration of dexramipexole was significantly related to the improvement of lung function

D-Pramipexole is a small oral molecule that is a selective inhibitor of eosinophil maturation and is used to treat asthma and other eosinophil-related diseases
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In hypereosinophilic syndrome, dexpramipexole has been shown in a phase 2 trial to significantly reduce the need for oral corticosteroids and produce lasting disease remission in a patient group

A randomized, double-blind, placebo-controlled EXHALE trial was conducted in patients with moderate to severe asthma who had an absolute blood eosinophil count (AEC) ≥300/µL
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In the trial, on the basis of the standard treatment of patients, an oral dose of 75 mg/day, 150 mg/day or 300 mg/day of dexramipexole was added

▲The molecular structure of dexpramipexole (photo source: Edgar181, Public domain, via Wikimedia Commons)

The trial reached its primary endpoint and showed a dose-dependent decrease in eosinophils
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At all test doses, AEC decreased significantly from baseline to week 12: 1) 75 mg/day: ratio to baseline 0.

The data released today showed that the reduction of eosinophils by dexramipexole was significantly related to the improvement of patients’ FEV1 before bronchodilator (combined with 300 mg/day and 150 mg/day dexramipexole, p<0.
0001 )
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In addition, dexpramipexole also has a dose-dependent effect on nasal eosinophil peroxidase (EPX) levels

In terms of safety, dexpramipexole was well tolerated in the EXHALE trial, with no serious adverse events and no adverse events leading to discontinuation of the drug
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74 of the 76 patients treated with dexpramipexole completed the main evaluation phase

Reference materials:

[1] Knopp Biosciences Presents New Phase 2 Data at ERS 2021 Demonstrating that Reduction in Eosinophil Count by Dexpramipexole Significantly Correlates with Improvement in Lung Function.

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