Knopp Biosciences has commenced patient enrolment in a Phase II clinical trial of dexpramipexole for the treatment of moderate-to-severe eosinophilic asthma.
Dexpramipexole is a small molecule immunologic developed to treat eosinophil-driven diseases such as asthma, hypereosinophilic syndromes (HES), and chronic rhinosinusitis with nasal polyps.
The randomised, double-blind, placebo-controlled, biomarker trial will assess the clinical effects of three different doses of oral dexpramipexole on peripheral blood eosinophil count.
It will be performed in approximately 100 patients for a period of 12 weeks.
The parallel-group, multi-centre, dose-ranging trial’s primary outcome measure is the change in absolute eosinophil count in blood from baseline to week 12, while secondary outcome measures include changes in pre-bronchodilator FEV1 and asthma control outcomes to week 12.
Knopp Biosciences president and CEO Michael Bozik said: “We estimate that there are more than two million moderate-to-severe eosinophilic asthma patients in the US and are excited about further characterising the clinical profile of oral dexpramipexole in this difficult-to-control disease.”
In May last year, the company reported positive results from a Phase II trial of the drug in ten HES patients.
The study met its co-primary endpoints of the proportion of patients with a 50% or greater decrease in minimally effective glucocorticoid dose (MED) and a decrease in glucocorticoid requirement.
Of the four patients who met the primary endpoint, three were observed to have achieved complete haematological responses. The drug was also well-tolerated and no adverse events requiring treatment disruption or discontinuation were recorded.
In April this year, dexpramipexole secured orphan drug designation from the US Food and Drug Administration (FDA) to treat HES.
The company also conducted a Phase II trial of the drug in chronic rhinosinusitis with nasal polyps.