Tag: Long-Peptide Immunotherapy
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 Phase II Dose Ranging Trial with Birch Pollen Allergy Vaccine AllerT
– Dose assessment for upcoming Phase III trial
Anergis, a company developing proprietary ultra-fast allergy vaccines, today announced the start of a Phase II trial designed to finalize the dose selection for the Phase III study of AllerT. AllerT is Anergis´ lead vaccine against birch pollen allergy that originated from the company´s proprietary Contiguous Overlapping Peptide (COP) platform. COPs are pharmaceutical-grade, long-peptide immunotherapeutics designed for an ultra-fast, safe and long-lasting treatment of allergy patients.
The randomized, double-blind, placebo-controlled, 4-parallel-group trial will assess the dose response efficacy of AllerT across doses of 50 µg, 25 µg, 10 µg compared to a placebo in an environmental exposure chamber (EEC). Approximately 180 birch pollen allergy patients will receive 5 subcutaneous injections over 2 months. All enrolled patients will be challenged with birch pollen prior to receiving AllerT or the placebo, and 4 weeks after the last injection.
The primary endpoint is the change in Total Rhinoconjunctivitis Symptom Scores (TRSS) from the baseline EEC challenge to the post-treatment EEC challenge.
Secondary endpoints are the mean Total Nasal Symptom Scores (TNSS), Total Ocular Symptom Score (TOSS), Individual Nasal Symptom Scores (NSS) and Asthma Symptom Score (ASS), which will also be evaluated from the baseline EEC challenge to the post-treatment EEC challenge. The trial is being conducted in Canada, with results expected in the third quarter of 2015.