Date: 2017-09-06
Type of
information: Results
phase: 2b
Announcement: results
Company: Anergis (Switzerland)
Product: AllerT
Action
mechanism:
- immunotherapy product. AllerT is a birch pollen allergy vaccine derived from the company´s proprietary Contiguous Overlapping Peptide (COP) technology platform, which is designed to provide ultra-fast allergy desensitization after only two months of treatment. This technology reproduces the complete amino acid sequence of the allergen in separate synthetic long peptides. COP allergy vaccines provide the complete allergen sequence covering all T cell epitopes, but do not cross-react with IgE, the antibody class responsible for eliciting allergic hypersensitivity. Therefore, COPs can be administered safely at high doses to induce tolerance to the allergen after a few injections only. This allows for desensitization in 2 months as opposed to 3 years.
Disease: birch pollen allergy
Therapeutic
area: Allergic diseases - Immunological diseases
Country: Denmark, Finland, Germany, Lithuania, Norway, Poland, Slovakia, Sweden
Trial
details:
- ATIBAR is the largest field-based trial conducted so far with an ultrafast allergy treatment for tree pollen allergy. The trial was designed as a confirmatory efficacy trial with efficacy endpoints and the statistical power required to meet both European and US FDA efficacy criteria for registration trials in allergy immunotherapy. Its primary efficacy endpoint is a combined symptom and medication score assessed daily in natural conditions during birch pollen season, based on the recommendations of the European Association of Allergy and Clinical Immunology (Allergy 2014, 69, 854-67).
Latest
news:
- • On September 6, 2017,– Anergis, announced the top-line results from the ATIBAR trial, a Phase IIb field-based clinical trial with its lead compound AllerT for patients with birch pollen allergy. The trial met its objective to provide conclusive results, with well-balanced treatment groups, very few dropouts, and narrow confidence intervals of the observed treatment effects. The pollen exposure was satisfactory as assessed by the data collected from the pollen traps located close to the trial centers. The trial met its primary endpoint with high statistical significance: the treatment effect of AllerT 50 µg vs placebo is a 7% improvement of the Combined Symptom and Medication Score (CSMS) with a 95% confidence interval of -2% to -11%, p=0.0047. This 7% improvement of the CSMS is driven by a 14% reduction of the
Symptom Score (RSS) without meaningful difference of the Medication Score (RMS).
- The primary endpoint results are supported by the main secondary endpoint miniRQLQ (quality of life questionnaire) results (AllerT 50 µg -9% vs placebo, p=0.0526). Additional strongly supportive data are significant reductions of the Asthma Symptom and Medication Score (-29%) and Nighttime Nasal Symptom Score (-35%), both p<0.0001.
The tolerability profile was similar to previous trials. Two grade 3 and two grade 4 systemic allergic reactions were reported in the AllerT 50 µg group. Anergis will now continue analyzing and interpreting the data of the trial. In parallel, the company has also started exploring strategic options including talking to external parties.
- • On February 8, 2017, Anergis announced that it has completed patient recruitment in the ATIBAR trial with AllerT for patients with birch pollen allergy. 421 patients were randomized at 38 European trial centers in Denmark, Finland, Germany, Lithuania, Norway, Poland, Slovakia and Sweden between September 2016 and January 2017. The study is designed to assess the efficacy and tolerability
of two dosing regimens of AllerT In Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis (ATIBAR). Patients with moderate to severe allergy to birch pollen were randomly allocated to receive one of three double-blind treatments
administered as 5 subcutaneous injections over 2 months: placebo, AllerT 50 µg or AllerT 10 µg. Top-line ATIBAR trial results are expected in the third quarter of 2017.
Is
general: Yes
