Date: 2015-10-23
Type of information: Results
phase: 2
Announcement: results
Company: Ares Allergy (UK)
Product: house dust mite sublingual immunotherapy tablet (STG320)
Action
mechanism: immunotherapy product
Disease: allergic asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country: France, Germany, Poland
Trial
details: This was a randomized, double-blind, placebo-controlled, dose ranging trial to assess the efficacy and safety of house dust mite sublingual immunotherapy tablets for the treatment of allergic asthma. Adults aged 18 to 50 years with medical history consistent with house dust mite-induced allergic asthma and rhinitis were eligible. A total of 386 patients from 11 European countries were randomized to receive 1 year of treatment with house dust mite sublingual immunotherapy tablets or placebo.(NCT01930461)
Latest
news: * On October 23, 2015, Ares Allergy provided an update on the development of its house dust mite (“HDM”) sublingual immunotherapy tablet (STG320) for the treatment of allergic asthma. A phase II study investigating the efficacy and safety of sublingual immunotherapy tablets of HDM allergen extracts in adults with HDM associated allergic asthma was conducted in 11 European countries with 386 randomized patients (study VO72.12). Although the study did not meet its primary endpoint (effect of treatment as compared to placebo on the Asthma Control Test™ score), the HDM sublingual tablet was shown to be active with clear evidence of a dose response based on its immunological activity. No unexpected adverse events were observed. Professor Pascal Demoly, from the University Hospital of Montpellier, France, the principal investigator for the VO72.12 study, commented: “This is an important milestone in Ares Allergy’s development program for HDM immunotherapy. The VO72.12 study has demonstrated that the HDM sublingual tablet is an active compound, with clear dose dependent immune response.”
