visionariesnetwork Team

07 October, 2025

biotechnology and pharmaceuticals

Positive trial boosts Areteia Therapeutics dexpramipexole

Areteia Therapeutics Inc., a Chapel Hill, N.C., clinical-stage biotech, announces positive EXHALE-4 Phase III study topline results for its orally delivered add-on therapy of dexpramipexole for eosinophilic asthma. The data are an important step towards Areteia's mission of delivering a widely available, oral substitute for injectable biologics for therapy of this severe form of asthma.

SPARC welcomes positive EXHALE-4 study

The EXHALE-4 Phase III trial enrolled patients at least 12 years of age with moderate-to-severe eosinophilic asthma, of which 600 were randomized to twice-daily dosing of 150 mg, 75 mg, or placebo of dexpramipexole, and stayed on background asthma medication. The primary end point of the trial was lung function improvement at Week 20 and Week 24, high-dose compared with placebo of dexpramipexole.

The results were extremely positive. Those treated with twice-daily dosing of 150 mg of dexpramipexole dramatically improved their lung function significantly more than patients treated with placebo, and meaningful improvement occurred by Week 4.

Both 150 mg and 75 mg groups also significantly reduced their blood eosinophils, thus vindicating it’s capacity to strike at the root of lung eosinophilic inflammation.

As reported by Areteia Therapeutics, dexpramipexole was tolerated, and its safety profile was consistent across previous studies. There were no new nor unexpected safety concerns, indicating potential for long-term administration of the oral therapy.

Overcoming a major clinical unmet need

Eosinophilia asthma occurs in over half of individuals suffering from asthma, a condition where a high number of white cells known as eosinophils lead to inflammation and airway constriction. Today's therapies for this subtype routinely involve injectable biologics, effective though they are, which are pricey and cumbersome for patients.

More than half of asthmatics have the eosinophilic form of asthma, yet there is a tremendous unmet need for orally delivered therapy, which is conveniently administered," commented Professor Ian Pavord, MA, DM, University of Oxford and Areteia Scientific Advisor.

If approved, Areteia Therapeutics dexpramipexole may become a paradigm-changing oral alternative, simplifying treatment for asthmatic patients who live with debilitating symptoms and few available therapeutic choices.

Company management and future prospects

“We are also excited to announce our EXHALE-4 Phase III trial's topline results, which reflect how our dexpramipexole fulfills patients living with eosinophilic asthma's unmet needs by increasing their lung capacity," said Jorge Bartolome, Areteia Therapeutics' president and CEO.

The corporation intends to release comprehensive study details at a future scientific assembly. Such results are likely to serve as a foundation for a prospective regulatory filing of dexpramipexole.

About Areteia Therapeutics

Established by Population Health Partners and Knopp Biosciences, Areteia Therapeutics is funded by premier life sciences and strategy investors. Areteia Therapeutics is dedicated to bringing about novel therapies for inflammatory airways diseases for their root causes.

With its successful trial of EXHALE-4, Areteia Therapeutics dexpramipexole takes a step forward towards being the first oral medication for eosinophilic asthma, bringing renewed hope for patients for easy, effective relief of their lifelong breathing problems.