Areteia Therapeutics has announced that positive topline results from the Phase II EXHALE-1 study of dexpramipexole for eosinophilic asthma have been published online in the Journal of Allergy and Clinical Immunology (JACI).
The Phase II randomised, double-blind, placebo-controlled proof-of-concept study (NCT04046939) sought to evaluate the safety and efficacy of dexpramipexole in lowering blood and airway eosinophilia in subjects with eosinophilic asthma. Participants included adults with inadequately controlled moderate to severe asthma and absolute eosinophil count (AEC) greater than or equal to 300/μL.
Participants were randomised (1:1:1:1) to dexpramipexole 37.5mg BID, 75mg BID or 150mg BID or placebo groups. The primary endpoint was the relative change in AEC from baseline to week 12. Prebronchodilator FEV1 week 12 change from baseline was a key secondary endpoint. Nasal eosinophil peroxidase was an exploratory endpoint.
Results of Phase II EXHALE-1 study
Dexpramipexole significantly reduced AEC at week 12 across all doses tested, with 77% and 66% reductions relative to placebo in the 150mg and 75mg twice daily (BID) dose groups, respectively. Dexpramipexole reduced the exploratory endpoint of nasal eosinophil peroxidase, a biomarker of tissue eosinophilic inflammation, in both the 150mg BID and the 75mg BID groups. Clinically meaningful improvements in lung function measured by forced expiratory volume (FEV1) were observed starting at week four.
Dexpramipexole was found to be safe and well-tolerated overall. Adverse events were balanced across treatment arms with no serious adverse events or discontinuations due to adverse events recorded. Of the 76 dexpramipexole-treated subjects, 74 (97%) completed the primary assessment phase on the study drug.
Dexpramipexole is an oral small-molecule eosinophil-lowering drug. It is an anti-sclerotic agent that increases the efficiency of mitochondria. It reduces the production of reactive oxygen species (ROS), attenuates the activation of apoptotic pathways, and increases cell survival in response to a variety of neurotoxins.
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Dexpramipexole leads to neuroprotection involving antiapoptotic, antioxidant, and antitoxic mechanisms, as well as inducing neurotrophic factors. Late-stage development of dexpramipexole in eosinophilic asthma has been initiated, with three Phase III clinical trials in partnership with Validae Health.
Asthma commonly affects over a quarter of a billion people worldwide with more than half attributed to eosinophilic asthma driven by an oversupply of eosinophils. Eosinophils are a type of white blood cell found in blood and tissue.