Anergis reports immunology data from AllerT Phase IIb study for birch pollen allergy

Oct 21 2013

Anergis, a company focusing on proprietary allergy vaccines, today reported immunology data from the Phase IIb study of its lead compound AllerT. In the trial, AllerT induced a strong increase of allergen-specific IgG4, a key marker of immunological responses typically observed in successful, conventional allergy immunotherapy (AIT, previously known as allergen-specific immunotherapy, or SIT). In September 2013, Anergis had reported that the trial showed significant clinical effects of AllerT on multiple efficacy endpoints, including combined symptom and medication scores assessed daily throughout the natural birch pollen season 2013.

In the placebo-controlled, double-blind, multicenter trial, a total of 240 patients from 24 European trial centers were randomized to receive 5 pre-seasonal injections of AllerT 50 μg, AllerT 100 μg, or placebo over a period of 2 months between November 2012 and March 2013.

Allergen-specific IgG4 antibody blood levels were similar in all three groups before treatment. Four weeks after completion of treatment and prior to the birch pollen season, the IgG4 levels were markedly and similarly increased in both AllerT dose groups by a factor of about 20 compared to baseline and to placebo (all tests p < 0.0001). During the subsequent birch pollen season, the IgG4 levels remained similarly elevated in both dose groups, showing that a plateau of IgG4 had been reached. By contrast, IgG4 levels remained unchanged in the placebo group during treatment and during the pollen season.

“We are very pleased with these highly significant IgG4 results, which are very similar to the immunological effects observed in the Phase I/IIa trial,” said Christophe Reymond, CSO of Anergis. “The long-term follow-up of this former trial also demonstrated the persistence of significantly elevated allergen-specific IgG4 levels up to four years after treatment.”

Prof. Marek Jutel (Wroclaw Medical University, Dept. of Immunology, Poland), a member of the Trial Steering Committee, added: “The data collected in this ultra-fast desensitization with AllerT show effects similar to conventional AIT from both clinical and immunological standpoints. We are eager to see AllerT being developed further and are focusing on additional COP allergy vaccines reaching clinical development stages.”

Anergis’ COP (Contiguous Overlapping Peptide) technology can be applied to a broad spectrum of allergy indications. At present, Anergis is developing AllerT for the treatment of birch pollen allergy, AllerR for ragweed pollen allergies and AllerDM for dust mite allergies.