The IAP considers the first phase III clinical study with gp-ASIT+ in the treatment of allergic rhinitis to grass pollen (BTT009) as a supportive study and asks a pivotal confirmation before considering a request for authorisation of the placing on the market
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The IAP considers that the reactivity to the TPC1 pre-treatment allows selection of patients most appropriate for a future phase III study
The post-hoc analysis of the trial BTT009 reveals that the combined score of clinical symptoms and drug intake (CDM) improved by 24% on the total duration of the pollen season in the group of patients with reactivity to the TPC, the higher prior to treatment (score 3 and 4), representing more than half of the patients in the trial
Brussels, Belgium, 19 June 2017, 7: 00 am (CEST) ASIT biotech (Euronext : ASIT — BE0974289218), a biopharmaceutical company focused on the belgian stage of the clinical development specialized in the research, development and future commercialization of a new generation of immunotherapy products innovative for the treatment of allergies, reports the comments of the Paul-Ehrlich-Institute (PEI, the health authority German), and publishes this day the detailed results of its phase III clinical study with gp-ASIT+, the conference 2017 of the EAACI (the European Academy of Allergology and Clinical Immunology) in Helsinki.
The IAP has invited ASIT biotech at a meeting of scientific advice to review the results of the test BTT009 and to agree on the roadmap clinical and regulatory. On the occasion of this meeting of scientific opinion, the PEI has recognized that the results of the primary endpoint analyzed in the group of patients as presented in the submitted documentation had reached the statistical significance (p