Tag: COP
Company News: Anergis Presents Sustained Efficacy Data from its AllerT Phase IIb Trial at the AAAAI Annual Meeting
– Contiguous Overlapping Peptide allergy immunotherapeutic AllerT confirms sustained efficacy in the second year following treatment
Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, presented detailed data from the Phase IIb trial of its birch pollen allergy immunotherapeutic AllerT in two separate scientific posters at the AAAAI (American Academy of Allergy, Asthma and Immunology) Annual Meeting in Houston, Texas. The findings were presented on February 22, 2015. Abstracts can be found at www.anergis.ch. AllerT is Anergis´ most advanced long-peptide immunotherapeutic and based on the company´s proprietary Contiguous Overlapping Peptide (COP) platform.
In 2013, the clinical efficacy of AllerT was demonstrated in a field-based, randomized, placebo-controlled, double-blind trial in 239 patients with birch pollen allergy, who received either AllerT (at 50μg or 100μg doses) or a placebo during a 2-month immunotherapy regimen. All main efficacy and safety endpoints were met in this study.
In 2014, the sustained efficacy of AllerT was assessed in the same group of patients during a second follow-up season without additional treatment. In both years, efficacy was evaluated using combined Rhinoconjunctivitis Symptom and Medication Scores (RSMS) as the primary endpoint as well as quality of life (Mini RQLQ) and Night-time Nasal Symptom Score (NNSS) as the main secondary endpoints. The study also measured the levels of allergen-specific immunoglobulins (Bet v 1 specific IgG4) in patients.
The data collected during the second post-treatment season (N=196 patients) proved the sustained efficacy of AllerT, as demonstrated by improvements in the primary endpoint, RSMS, and in the main secondary endpoints, Mini RQLQ and NNSS. The trial also confirmed that AllerT had induced a persistent elevation of anti-Bet v 1 IgG4 antibodies, i.e. measured after one year without treatment.
Company News: Anergis Starts European Phase IIb Clinical Trial with AllerT in Patients with Moderate to Severe Allergy to Birch Pollen
– First patient treated with novel allergy vaccine –
Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, reported today that it has treated the first patient in a large, well-controlled Phase IIb clinical trial in individuals with birch pollen allergy. The trial is designed to evaluate the efficacy and tolerability of a 5-injection / 2- months treatment with Anergis´ lead allergy vaccine, AllerT.
The multicentre, double-blind, placebo-controlled, randomized trial called AN004T was designed in collaboration with an International Steering Committee of experts with comprehensive experience in the design and conduct of allergen-specific immunotherapy trials(1). The trial will enroll about 300 patients with moderate to severe birch pollen allergy from up to 30 trial centers throughout Europe. Trial centers are located in Denmark, France, Latvia, Lithuania, Poland, Sweden and Switzerland. AN004T will evaluate the efficacy and safety of two doses of AllerT in comparison with placebo. The first patient was randomized and treated on November 3rd, 2012, in Vilnius, Lithuania.
As recommended by the European Guideline on the Clinical Development of Products for Specific Immunotherapy for the Treatment of Allergic Diseases (CHMP/EWP/18504/2006), the efficacy of AllerT will be assessed using a combined symptom and medication score as primary endpoint of the trial (combined Rhinoconjunctivitis Symptom and Medication Score RSMS). RSMS assessment is based on allergy symptom and medication data reported through electronic diaries by the trial subjects during the 2013 birch pollen season. Secondary and exploratory endpoints will include other clinical parameters related to symptoms and/or medications taken for allergy, as well as quality of life and immunological marker assessments.