A phase II trial of a novel drug, dexpramipexole, showed positive top-line results in patients with moderate-to-severe eosinophilic asthma, announced Knopp Biosciences.
Dexpramipexole is a selective inhibitor of eosinophil maturation. The randomised, double-blind phase II EXHALE study analysed the efficacy and safety of a daily dose of 75mg/150mg/300mg of oral dexpramipexole versus placebo in lowering blood eosinophil counts over 12 weeks.
The study was carried out in 103 adult participants with moderate-to-severe eosinophilic asthma.
According to the company, the drug showed a statistically significant, dose-dependent reduction in blood absolute eosinophil count (AEC) at 12 weeks versus placebo, along with the standard of care (SoC).
Inhaled corticosteroids plus a long-acting β2 agonist was the background SoC. Furthermore, the magnitude of change in blood AEC was similar to the eosinophil depletion as observed in trials of dexpramipexole for other indications.
A reduction of eosinophil in blood with the use of oral dexpramipexole was linked to clinically significant improvement in lung function as measured by pre-bronchodilator FEV1.
All tested doses of the drug were observed to be well tolerated with no serious adverse events noted, said the company.
“This phase II results strongly support the continued development of dexpramipexole as a potential first-in-class oral agent for the treatment of eosinophilic asthma,” said Knopp president and CEO Michael Bozik.
“We expect future studies to determine the drug’s effects on severe asthma exacerbations, and to further assess its effects on lung function,” he added.