First use of a DNA-based drug candidate: Phase 1 study investigates novel therapy for house dust mite allergy

Allergic rhinitis caused by house dust mites is widespread worldwide and significantly impacts the quality of life of affected patients. While conventional treatment options such as allergen avoidance, pharmacotherapy, and allergen immunotherapy are available, they are associated with limitations, including lengthy treatment durations and the risk of adverse effects. In a Phase I clinical study conducted at Fraunhofer ITEM, a novel LAMP-based DNA therapeutic approach (ASP2390) for house dust mite allergy was investigated in humans for the first time.

The clinical trial was conducted in the Fraunhofer Allergen Challenge Chamber, which enables standardized and reproducible exposure to precisely defined concentrations of house dust mite allergens. In this randomized, double-blind study, 28 adults with diagnosed house dust mite allergy received either the investigational product ASP2390 or placebo over 12 weeks. Safety, tolerability, and initial efficacy signals were assessed over a total study duration of 63 weeks. The study demonstrated that ASP2390 was safe and well tolerated, with no serious adverse events and no treatment discontinuations. However, compared with the placebo group, neither immunological nor clinical efficacy could be demonstrated.

Overall, the results confirm that validated exposure models in the Fraunhofer Allergen Challenge Chamber are central to reliably assessing the potential of innovative approaches for safe and effective allergy therapies in early-stage clinical studies. The findings were published in The Journal of Allergy and Clinical Immunology: Global; DOI: 10.1016/j.jacig.2025.100404.