Areteia Therapeutics Advances Oral Dexpramipexole for Eosinophilic Asthma in Phase III Trials
Key Insights
Areteia Therapeutics (search) is progressing dexpramipexole, a novel oral therapy, into Phase III clinical trials for severe eosinophilic asthma (search).
Dexpramipexole aims to reduce eosinophil levels by inhibiting their maturation in the bone marrow, offering a potential alternative to injectable biologics.
Akero Therapeutics will present updates on its MASH (search) treatment, EFX, currently in Phase 3 trials, at the J.P. Morgan Healthcare Conference.
Areteia Therapeutics (search) is advancing its investigational drug, dexpramipexole, into Phase III clinical trials for the treatment of severe eosinophilic asthma (search). The company will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025, in San Francisco, CA, to discuss the development program.
Dexpramipexole is an oral small molecule designed to lower eosinophil levels in both blood and tissue. The Phase III program includes two 52-week global exacerbation trials and one 24-week lung function trial. The drug's mechanism of action involves inhibiting the maturation of eosinophils in the bone marrow, potentially reducing peripheral blood eosinophil levels.
Clinical Data and Potential
In a Phase II study, dexpramipexole demonstrated a significant, dose-dependent reduction in blood absolute eosinophil count across all tested doses (37.5-mg, 75-mg, or 150-mg twice daily) compared to placebo in patients with moderate-to-severe eosinophilic asthma (search). The drug was well-tolerated, with adverse events balanced between treatment and placebo groups, and no serious adverse events leading to discontinuation.
Eosinophilic Asthma and Current Treatment Landscape
Asthma affects over a quarter of a billion people worldwide, with more than half having eosinophilic asthma (search), characterized by an oversupply of eosinophils. Current treatments include injectable anti-IL-5/5R biologic therapies, which have driven the global asthma biologic market to approximately $10 billion. Dexpramipexole, if approved, could offer a first-to-market oral alternative to these injectable biologics.
Akero Therapeutics' MASH Program
In related news, Akero Therapeutics is also scheduled to present at the J.P. Morgan Healthcare Conference on the same day. Akero will provide updates on EFX, its lead product candidate for Metabolic dysfunction-associated steatohepatitis (MASH (search)). EFX is currently being evaluated in three Phase 3 clinical trials: SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes, targeting patients with pre-cirrhotic MASH (F2-F3) or compensated cirrhosis (F4) due to MASH.