Areteia’s oral asthma drug shows positive Phase III results

Areteia Therapeutics Inc., a clinical-stage biotechnology company based in Chapel Hill, has reported positive results from the Phase III EXHALE-4 efficacy and safety study of the investigational drug dexpramipexole as an add-on oral therapy for eosinophilic asthma.

Areteia is developing dexpramipexole for adults with moderate to severe eosinophilic asthma, a type of asthma in which high levels of white blood cells known as eosinophils cause airway inflammation and breathing difficulties.

“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 in the UK and a member of Areteia’s Scientific Advisory Board.

If approved, dexpramipexole could give patients an easy-to-take oral option instead of injectable biologics, which are currently the only treatment for this type of 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,” said Jorge Bartolome, president and chief executive officer of Areteia. 

Asthma trial findings

EXHALE-4 is a Phase III trial in 600 patients aged 12 and older with moderate-to-severe asthma and high blood eosinophils. Participants continued their regular asthma medications and were randomly assigned to take 150 mg or 75 mg of dexpramipexole twice daily or a placebo. The study compares the 150 mg dose to a placebo by measuring lung function improvement at Weeks 20 and 24 while also studying the 75 mg dose’s effects on eosinophil levels.

Initial results showed that dexpramipexole significantly improved lung function, averaged over Weeks 20 and 24, in the group taking dexpramipexole 150 mg twice daily compared with placebo. Significant improvements in lung function were observed as early as week 4.

The study also showed significantly reduced blood absolute eosinophil counts, averaged over Weeks 20 and 24, for patients taking 150 mg or 75 mg twice a day compared with placebo. Dexpramipexole was well tolerated in the study, with a safety profile similar to previous studies.

The company plans to present full study results at an upcoming medical meeting.  Areteia was founded by Population Health Partners and Knopp Biosciences, with a group of leading life sciences and strategic investors supporting the company’s launch and the development of dexpramipexole.