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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
.
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
.
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
.
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
.
At all test doses, AEC decreased significantly from baseline to week 12: 1) 75 mg/day: ratio to baseline 0.
40, p=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 )
.
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
.
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.
(The original text has been deleted)
