Tag: ultra-fast desensitization

Company News: Immunology Data Further Underline the Positive Outcome of a Phase IIb Trial of Anergis´ Birch Pollen Allergy Vaccine AllerT

– Treatment with AllerT increases allergen-specific IgG4 antibody levels by a factor of 20

– AllerT administration produces humoral immune responses similar to conventional desensitization

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.

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.

Company News: Anergis Files Provisional U.S. Patent on AllerDM Dust Mite Allergy Treatment

– Further expansion of the company’s product pipeline and patent estate –

Anergis, a company focusing on proprietary synthetic allergy vaccines designed to provide ultra-fast desensitization, has filed for provisional patent protection of its AllerDM dust mite allergy treatment in the U.S. The company plans to extend the patent application within the next 12 months to achieve world-wide protection under the Patent Cooperation Treaty.

AllerDM is an allergy vaccine for patients with house dust mite allergy and is based on Anergis’ proprietary Contiguous Overlapping Peptide (COP) technology, which allows for ultra-fast desensitization in only two months treatment. COP allergy vaccines are pharmaceutical quality products, which have proven to be safe and well tolerated and to induce a long-term immune effect. AllerDM is currently in pre-clinical development and is expected to enter clinical stage in 2015. Further details on the product are not being disclosed at present.

House dust mites are the most frequent cause of allergy and suspected to trigger severe consecutive disorders. Asthma may be caused by house dust mite allergy in 50 to 80% of patients. It is estimated that about 60 million patients in Europe, 30 million in the U.S., 20 million in Japan and 60 million in China suffer from dust mite allergies.

AllerT, the lead product of Anergis, is currently evaluated in a double-blind, randomized, placebo-controlled Phase IIb trial in 240 patients with moderate to severe birch pollen allergy, enrolled at 24 trial centers throughout Europe. Results are expected in Q3, 2013.

Earlier this year, Anergis presented preclinical data of its ragweed allergy vaccine candidate AllerR. A Phase I/IIa trial of AllerR is expected to start in 2015.


1 2