Poster concludes that change in FEV1 was correlated with change in blood absolute eosinophil count (AEC), demonstrating the link between eosinophil depletion and clinical benefit
Knopp Biosciences LLC today reported further clinical data from its Phase 2 Exhale t**** demonstrating oral dexpramipexole improves airflow obstruction in asthma as measured by FEV1, largely through its effect on FVC. Change in FVC was the dominant contributor to increases in FEV1, which suggests that by lowering eosinophils in the airway lumen, dexpramipexole may act to decrease mucus plugging and air trapping in small airways. As previously reported, dexpramipexole produced clinically meaningful increases in FEV1 across study arms and time points.
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The data were presented over the weekend as a poster during the American Academy of Allergy Asthma & Immunology (AAAAI) meeting in Phoenix, AZ.
Eosinophils, a type of white blood cell, are a validated therapeutic target in asthma, as evidenced by the regulatory approval of multiple eosinophil-lowering biologics. Treatments approved to date for eosinophilic asthma are monoclonal antibodies requiring injection or infusion; dexpramipexole is administered orally.
“These results provide new insight into the effects of eosinophils on pulmonary physiology, and further strengthen the hypothesis that reductions in blood and tissue eosinophils by dexpramipexole are associated with improved lung health,” said Calman Prussin, M.D., Chief Medical Officer of Knopp.
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As previously reported, dexpramipexole was well tolerated in the EXHALE t****, with 97% of dexpramipexole-treated patients completing the primary assessment phase. There were no serious adverse events and no adverse events leading to discontinuation.
“We are excited to be rapidly moving into Phase 3 clinical development, with the goal of securing regulatory approvals from health authorities around the world, and provide a first-in-class oral therapeutic option for millions of eosinophilic patients,” said Michael Bozik, M.D., CEO of Knopp.
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