Company News: Anergis Announces Top Line Results from Large-Scale ATIBAR Trial with Ultra-Fast Allergy Immunotherapy AllerT
– Primary endpoint met: Combined Symptom and Medication Score in the AllerT 50 µg group is 7% lower than in the placebo group (p = 0.0047) over the entire birch pollen season
– Rhinoconjunctivitis Symptom Score in the AllerT 50 µg group is 14% lower than in the placebo group (p < 0.0001)
– Nighttime Nasal Symptom Score in the AllerT 50 µg group is 35% lower than in the placebo group (p<0.0001)
– Asthma Symptom and Medication Score in the AllerT 50 µg group is 29% lower than in the placebo group (p<0.0001)
Anergis, a company developing proprietary ultra-fast allergy immunotherapy, announced today the top-line results from the ATIBAR trial, a Phase IIb field-based clinical trial with Anergis’ lead compound AllerT for patients with birch pollen allergy.
A total of 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 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 mini-RQLQ (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.
“We are very thankful to the trial investigators, patients and all study personnel who contributed to the achievement of this high quality ATIBAR trial. We have met all our objectives to produce highly reliable results with precise estimates of the treatment effect of AllerT,” said Kim Simonsen, MD, Chief Development Officer of Anergis.
Vincent Charlon, PhD, CEO of Anergis, added: “While we are very satisfied with the trial performance and the high level of statistical significance achieved in this trial, we are surprised that the magnitude of efficacy is substantially lower than in our previous seasonal field trial (e.g. AN004T, CSMS difference from placebo -26%, p=0.01). We will continue analyzing and interpreting the data of the trial. In parallel, we have also started exploring strategic options including talking to external parties.”