CHAPEL HILL, N.C.– Areteia Therapeutics, Inc. announced today positive topline results from the Phase III EXHALE-4 trial evaluating dexpramipexole as an add-on oral therapy for eosinophilic asthma. The study met its primary endpoint, showing statistically significant improvement in lung function compared with placebo, and also demonstrated a significant reduction in blood absolute eosinophil count (AEC).
“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 and a member of Areteia’s Scientific Advisory Board. “The EXHALE-4 results are extremely promising, showing both improved lung function and reduced eosinophil counts with dexpramipexole, which has the potential to become the first oral treatment for eosinophilic asthma.”
The study found that dexpramipexole 150 mg twice daily 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). Improvements were evident as early as Week 4. In addition, both the 150 mg BID and 75 mg BID doses produced significant reductions in blood AEC over the same timeframe.
Dexpramipexole was well tolerated, with a safety profile consistent with earlier trials.
“We are pleased to report positive topline results for EXHALE-4, which demonstrate dexpramipexole’s potential to address the unmet needs of people with eosinophilic asthma by improving their lung function,” said Jorge Bartolome, President and Chief Executive Officer of Areteia. “We look forward to sharing the full EXHALE-4 results at an upcoming medical meeting, while continuing enrollment in the EXHALE-2 and EXHALE-3 studies as we advance our goal of transforming the patient journey.”
Dexpramipexole remains an investigational therapy and has not yet been approved for use in eosinophilic asthma.
