Dexpramipexole Improves Lung Function in Eosinophilic Asthma, reveals research

The phase 3 EXHALE-4 study demonstrated that dexpramipexole, an oral small molecule therapy, significantly improved pre-bronchodilator FEV1 compared with placebo when used as an add-on treatment in patients with eosinophilic asthma. These findings highlight dexpramipexole's potential as a novel therapeutic option for improving lung function in this patient population.

“More than half of people with asthma have the eosinophilic subtype, yet there remains a profound need for easily administered oral treatment options that can help address their symptoms, which are often severe,” said Ian Pavord, MA, DM, Professor of Respiratory Medicine at the University of Oxford, UK and a member of Areteia’s Scientific Advisory Board.

“Initial results from the Phase III EXHALE-4 study are extremely promising, particularly the statistically significant improvement in lung function and the reduction in eosinophils observed with dexpramipexole versus placebo, which show the potential for dexpramipexole to become the first oral treatment approved for eosinophilic asthma.”

“We are pleased to report positive topline results for the EXHALE-4 Phase III study, which demonstrate dexpramipexole’s ability to address the unmet needs of people with eosinophilic asthma by improving their lung function. Dexpramipexole has the potential to be the first oral treatment for this indication,” said Jorge Bartolome, President and Chief Executive Officer of Areteia. “We look forward to presenting the full EXHALE-4 results at an upcoming medical meeting as we also advance the EXHALE-2 and EXHALE-3 studies and work to transform the patient journey in eosinophilic asthma.”

Dexpramipexole significantly improved lung function averaged over Weeks 20 and 24, as measured by the change from baseline in pre-bronchodilator forced expiratory volume (pre-BD FEV1), in the dexpramipexole 150 mg twice daily (BID) group compared with placebo. Significant improvements in lung function were observed as early as Week 4.

Dexpramipexole 150 mg BID and 75mg BID significantly reduced blood AEC averaged over Weeks 20 and 24, as measured by the change from baseline in geometric mean AEC values compared with placebo.

In this study, dexpramipexole was well tolerated, with a safety profile similar to previous studies.

Full study results will be presented at an upcoming medical meeting. Dexpramipexole is an investigational drug and is not licensed for use in eosinophilic asthma.