Areteia Therapeutics has announced promising topline results from its phase 3 EXHALE-4 clinical trial, which evaluated the efficacy and safety of dexpramipexole, an investigational oral therapy for eosinophilic asthma. The study met its primary endpoint, showing statistically significant improvements in lung function and reductions in blood eosinophil levels compared to a placebo.
Eosinophilic asthma, a subtype affecting more than half of asthma patients, is characterized by elevated eosinophil counts and often requires complex treatment regimens. Dexpramipexole, if approved, could become the first oral therapy for this condition, offering a more convenient alternative to injectable biologics.
“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, in a company press release. Dr. Pavord is a professor of respiratory medicine at the University of Oxford in England and a member of Areteia’s Scientific Advisory Board. “The improvements in lung function and eosinophil reduction suggest dexpramipexole could significantly impact treatment for eosinophilic asthma.”
The EXHALE-4 trial enrolled 600 participants aged 12 and older with moderate-to-severe asthma and elevated eosinophil counts. Participants continued their standard asthma treatments while receiving either dexpramipexole or placebo. The 150 mg twice-daily dose of dexpramipexole showed significant improvements in pre-bronchodilator FEV1 (a key measure of lung function) as early as week four, sustained through weeks 20 and 24. Both 150 mg and 75 mg doses also significantly reduced blood eosinophil counts.
Dexpramipexole was well tolerated, with a safety profile consistent with earlier studies. The yet unpublished results will be presented at a future medical meeting, the company said.
Areteia is also continuing enrollment in two additional phase 3 trials (EXHALE-2 and EXHALE-3), which are focused on reducing asthma exacerbations over 52 weeks.
“Dexpramipexole has the potential to transform the patient journey in eosinophilic asthma,” said President and CEO of Areteia Jorge Bartolome.
The investigational drug works by inhibiting eosinophil maturation in the bone marrow, thereby reducing their presence in blood and tissue.
