Therapy Areas: AIDS & HIV
Phase II Data of Oral Dexpramipexole Published in Eosinophilic Asthma
8 August 2023 - - Results from the Phase II EXHALE-1 study of dexpramipexole have been published online in the Journal of Allergy and Clinical Immunology, US-based Areteia Therapeutics, Inc said.

The study sought to evaluate the safety and efficacy of dexpramipexole in lowering blood and airway eosinophilia in subjects with eosinophilic asthma.

Dexpramipexole significantly reduced AEC at week 12 across all doses tested, with 77% and 66% reductions relative to placebo in the 150-mg and 75-mg twice daily dose groups, respectively.

Dexpramipexole reduced the exploratory end point of nasal eosinophil peroxidase, a biomarker of tissue eosinophilic inflammation, in both the 150-mg BID and the 75-mg BID groups.

Clinically meaningful improvements in lung function as measured by forced expiratory volume were observed starting at week 4. Dexpramipexole displayed a favorable safety profile.

The study was a randomized, double-blind, placebo-controlled proof-of-concept trial in adults with inadequately controlled moderate to severe asthma and AEC greater than or equal to 300/μL.

Subjects were randomly assigned (1: 1: 1: 1) to dexpramipexole 37.5-mg BID, 75-mg BID or 150-mg BID or placebo.

The primary end point was the relative change in AEC from baseline to week 12. Prebronchodilator FEV1 week 12 change from baseline was a key secondary end point. Nasal eosinophil peroxidase was an exploratory end point.

A total of 103 subjects were randomly assigned to dexpramipexole 37.5-mg BID (N = 22), 75-mg BID (N = 26), 150-mg BID (N = 28), or placebo (N = 27).

Dexpramipexole significantly reduced placebo-corrected AEC week 12 ratio to baseline, in both the 150-mg BID (ratio, 0.23; 95% CI, 0.12-0.43; P