Date: 2015-04-01
Type of
information: Completion of the trial
phase: 2
Announcement: completion of the trial
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:
Trial
details:
Latest
news:
- • On April 1, 2015, Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, announced treatment completion of its Phase II clinical trial of AllerT, a novel long-peptide immunotherapeutic to treat birch pollen allergies. In the trial, 213 patients were randomized to receive target doses of 10, 25 or 50 µg of AllerT or placebo as 5 subcutaneous injections over 2 months. The last patient was treated at the end of March. No serious adverse events and no grade 3 or 4 allergic reactions were reported. The trial is being conducted in Canada and is still blinded. Results are expected in Q3 of 2015. “The trial results will support us in selecting the optimum dose regimen for Phase III, which we plan to start next year," said Vincent Charlon, Chief Executive Officer of Anergis.
- • On December 11, 2014, Anergis announced the start of a Phase II trial designed to finalize the dose selection for the Phase III study of AllerT. 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. \"In our previous field-based Phase II trials, we have seen that AllerT was similarly efficacious at 100 µg and 50 µg doses,\" said Vincent Charlon, Chief Executive Officer of Anergis. \"We therefore decided to further investigate the dose response of AllerT prior to launching the Phase III study.\"
Is
general: Yes
