Knopp Biosciences LLC today announced the start of Phase 2 dose-ranging clinical trial in moderate-to-severe eosinophilic asthma.
Recruitment in the trial is underway and the first patient has been enrolled. The Company anticipates reporting top-line data from this trial in the second half of 2020.
This 12-week biomarker study is planned to randomize approximately 100 patients with eosinophilic asthma to investigate the eosinophil response to three different doses of oral dexpramipexole. The primary outcome measure of this randomized, double-blind, placebo-controlled study is the change in blood absolute eosinophil count from Baseline to Week 12. The secondary outcome measures include changes in pre-bronchodilator FEV1 and asthma control outcomes (ACQ-7 questionnaire) from baseline to week 12.
“We estimate that there are more than two million moderate-to-severe eosinophilic asthma patients in the U.S. and are excited about further characterizing the clinical profile of oral dexpramipexole in this difficult-to-control disease,” said Michael E. Bozik, M.D., President and CEO of Knopp Biosciences.
Eosinophils are white-blood cells that play a central role in a number of debilitating diseases, including asthma, hypereosinophilic syndrome (HES), eosinophilic gastroenteritis, and atopic dermatitis. Knopp has previously reported the highly significant eosinophil-lowering effects of oral dexpramipexole including positive Phase 2 clinical trial results in HES.
Source: Company Press Release