Knopp Biosciences LLC and the University of Leicester have announced timelines, trial details, and eligibility criteria for a planned Phase 2 clinical trial evaluating the oral eosinophil-lowering drug candidate dexpramipexole in severe eosinophilic asthma patients that is on track to begin in the first half of 2020.
The 52-week, randomized, double-blind, placebo-controlled trial will evaluate whether dexpramipexole is associated with a reduction in asthma exacerbations. Fifteen severe asthma centers across the United Kingdom (UK) will be enrolling up to 100 total participants in the trial, led by the Leicester Clinical Trials Unit of the University of Leicester.
“We are pleased to collaborate with world-renowned asthma investigators in the UK to assess the effects of oral dexpramipexole on asthma exacerbations,” said Michael Bozik, M.D., president and CEO of Knopp. “An unmet need remains for an orally administered medicine for eosinophilic asthma, and we welcome the opportunity to assess dexpramipexole as an alternative to injectable biologic treatments.”
Salman Siddiqui, M.D., Ph.D., Professor of Airway Diseases at the University of Leicester and Consultant Respiratory Physician at Leicester’s Hospitals, will serve as the Chief Investigator for the study. The clinical program is chiefly funded by the National Institute for Health Research (NIHR) and Medical Research Council (MRC) of the UK, with the drug candidate, matching placebo, and additional support provided by Knopp Biosciences.
The primary outcome measure is the annual rate of asthma exacerbations. Secondary outcomes include changes from baseline in Asthma Control Score (ACQ-6), lung function (FEV1), fractional exhaled nitric oxide (FeNO) levels, and a number of quality-of-life-related measures. Eligibility criteria include a history of exacerbation-prone asthma and elevated blood eosinophils (≥0.30 x109/L cells). Patients who have failed monoclonal antibody therapy are eligible to participate in the trial after a period of biologic washout (5 months).
Dexpramipexole is an orally available small molecule drug candidate shown to selectively reduce eosinophil levels in multiple clinical trials, including in a Phase 2 study in hypereosinophilic syndrome (HES) and a Phase 2 trial in chronic rhinosinusitis with nasal polyps. Knopp has separately initiated a Phase 2 dose-ranging biomarker trial in the United States of oral dexpramipexole in moderate-to-severe eosinophilic asthma. Eosinophils are white-blood cells that play a central role in several debilitating conditions, including asthma, HES, and other inflammatory diseases.
Source: Company Press Release