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Late Breaking Abstract - Phase 2 trial evaluating the effects of dexpramipexole on blood eosinophils, lung function, and airway biomarkers in eosinophilic asthma

Salman Siddiqui, Michael Bozik, Donald Archibald, Steven Dworetzky, James Mather, Randall Killingsworth, Sergei Ochkur, Elizabeth Jacobsen, Reynold Panettieri, Calman Prussin
European Respiratory Journal 2021 58: RCT2900; DOI: 10.1183/13993003.congress-2021.RCT2900
Salman Siddiqui
1NIHR Biomedical Research Centre (Leicester) and College of Life Sciences, University of Leicester, UK., Leicester, United Kingdom
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  • For correspondence: ss338@leicester.ac.uk
Michael Bozik
2Knopp Biosciences LLC, Pittsburgh, United States of America
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Donald Archibald
2Knopp Biosciences LLC, Pittsburgh, United States of America
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Steven Dworetzky
2Knopp Biosciences LLC, Pittsburgh, United States of America
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James Mather
2Knopp Biosciences LLC, Pittsburgh, United States of America
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Randall Killingsworth
2Knopp Biosciences LLC, Pittsburgh, United States of America
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Sergei Ochkur
3Mayo Clinic, Scottsdale, United States of America
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Elizabeth Jacobsen
3Mayo Clinic, Scottsdale, United States of America
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Reynold Panettieri
4Rutgers Institute for Translational Medicine and Science, New Brunswick, United States of America
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Calman Prussin
2Knopp Biosciences LLC, Pittsburgh, United States of America
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Abstract

Background: Dexpramipexole is an oral drug that depletes eosinophils by inhibiting their maturation.

Objectives: Evaluate the safety and efficacy of dexpramipexole in subjects with poorly controlled moderate-severe eosinophilic asthma with absolute eosinophil count (AEC) ≥0.30x109/L.

Methods: AS201 was a randomized, double-blind, placebo-controlled trial (NCT04046939). 103 subjects were randomized 1:1:1:1 to receive dexpramipexole 75, 150, & 300 mg/day and placebo (PBO) for 12 weeks. The primary endpoint was change in blood AEC from Baseline to Week 12. Secondary endpoints included change from Baseline to Week 12 in pre-bronchodilator (BD) FEV1. Nasal eosinophil peroxidase (EPX), a measure of tissue eosinophils, was an exploratory endpoint.

Results: At 12 Weeks, AEC was reduced by 79.5% (p<0.001), 69.4% (p=0.001), and 59.7% (p=0.019) in the 300, 150, & 75 mg/day arms, respectively (p values vs. PBO). Dexpramipexole 300 mg/day resulted in a PBO-corrected pre-BD FEV1 change from Baseline of 271 mL (p=0.0083), 182 mL (p=0.0999), and 240 mL (p=0.0242) at Weeks 8, 12 and 16/18, respectively. At Week 12, pre-BD ∆FEV1 was correlated with ∆AEC, Spearman correlation coefficient -0.58, p<0.001 (combined 300 and 150 mg/day arms). At Week 12, nasal EPX was reduced by 89.0% (p=0.020), 82.6% (p=0.021), 35.5% (p=0.540), and 16.7%, for the 300, 150, & 75 mg/day and PBO arms, respectively (p values relative to PBO). Adverse events were similar between the dexpramipexole-treated and PBO arms.

Conclusions: Dexpramipexole was well-tolerated and effective in lowering eosinophils and improving FEV1 in a population of poorly controlled moderate-severe asthmatics.

  • Asthma
  • Severe asthma
  • Inflammation

Footnotes

Cite this article as: European Respiratory Journal 2021; 58: Suppl. 65, RCT2900.

This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.

This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).

  • Copyright ©the authors 2021
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Late Breaking Abstract - Phase 2 trial evaluating the effects of dexpramipexole on blood eosinophils, lung function, and airway biomarkers in eosinophilic asthma
Salman Siddiqui, Michael Bozik, Donald Archibald, Steven Dworetzky, James Mather, Randall Killingsworth, Sergei Ochkur, Elizabeth Jacobsen, Reynold Panettieri, Calman Prussin
European Respiratory Journal Sep 2021, 58 (suppl 65) RCT2900; DOI: 10.1183/13993003.congress-2021.RCT2900

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Late Breaking Abstract - Phase 2 trial evaluating the effects of dexpramipexole on blood eosinophils, lung function, and airway biomarkers in eosinophilic asthma
Salman Siddiqui, Michael Bozik, Donald Archibald, Steven Dworetzky, James Mather, Randall Killingsworth, Sergei Ochkur, Elizabeth Jacobsen, Reynold Panettieri, Calman Prussin
European Respiratory Journal Sep 2021, 58 (suppl 65) RCT2900; DOI: 10.1183/13993003.congress-2021.RCT2900
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