Results expected for Q3, 2014
April 23, 2014
Anergis, a company discovering and developing proprietary allergy vaccines, today announced that it has completed the enrolment of 196 subjects in the long-term efficacy trial of its birch pollen allergy vaccine AllerT, and expects to release results in the third quarter of 2014.
The long-term efficacy trial of AllerT is a double-blind, placebo-controlled, field-based clinical trial assessing the persistence of the efficacy of AllerT in post-treatment years.
All 196 patients participated in the field-based Phase IIb trial with AllerT in 2013. They all received a two-month double-blind, randomized treatment with AllerT or a placebo prior to the 2013 birch pollen season, and were then followed for efficacy during the 2013 birch pollen season, i.e. in conditions of natural pollen exposure. Last year’s Phase IIb trial had shown the efficacy of AllerT on allergy symptoms during the first post-treatment birch pollen season, based on combined symptom and medication scores, quality of life and other endpoints.
In the new long-term efficacy trial, 196 patients were enrolled and agreed to collect their daily allergy symptoms and allergy medication using electronic diaries, exactly as was done during the previous trial/season. The patients have not received any further investigational treatment since their pre-seasonal two-month treatment in early 2013.
The trial will thus provide efficacy data for AllerT during the second season post-treatment without any intervention since the initial two-month, pre-seasonal treatment. Anergis had already shown that patients from the AllerT Phase IIa trial had a persistent elevation in allergen-specific antibodies (IgG4) until at least the fourth post-treatment season.
Anergis SA is a Swiss-based biopharmaceutical company specializing in the discovery and development of novel, proprietary allergy vaccines that target commercially attractive indications. Anergis´ vaccines are based on its IP-protected Contiguous Overlapping Peptide (COP) technology. Allergies are the most prevalent and fastest growing chronic conditions in the industrialized world affecting over 500 million people.
Anergis’ lead-product AllerT, a vaccine to treat birch pollen allergies, is due to enter Phase III clinical development. Two additional vaccine candidates against ragweed pollen allergies (AllerR) and house dust mite allergies (AllerDM) are in preclinical development.
Anergis has raised over CHF 30 million from Renaissance PME/Vinci Capital, Sunstone Capital, BioMedInvest and other investors, including Esperante Ventures and Initiative Capital Romandie/Defi Gestion.
About Anergis´ Contiguous Overlapping Peptides (COP) Technology
The only curative therapy of allergies available today, known as “desensitization” or “Conventional Allergy Immunotherapy” (AIT), is the process of inducing tolerance to the allergen. It requires 3-5 years of treatment and exposes patients to the risk of serious side effects – in particular immediate (<30 min) anaphylactic reactions – which can be life-threatening. With its ultra-fast desensitization, Anergis is shaping the future of allergy treatment. Anergis’ vaccines are based on COPs which reproduce the complete amino acid sequence of the allergen in separate synthetic long peptides. COP allergy vaccines are pharmaceutical quality products that provide the complete allergen sequencing of 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 independent of MHC restriction and at high doses to induce tolerance to the allergen after only a few injections. This enables desensitization in 2 months as opposed to 3 years. Studies of COPs targeting bee venom and birch pollen allergies in both animals and humans have demonstrated excellent safety (i.e. no immediate allergic reaction) and immunogenicity (production of specific antibodies and cytokines against the original allergen and establishment of a long-term immune memory).
Vincent Charlon, CEO
Dr. Ludger Wess, Ines-Regina Buth
Tel. +49 40 88165964 or +49 30 2363 2768