Anergis Reports Positive Phase IIb Data for Birch Pollen Allergy Vaccine AllerT
- AllerT 50 μg meets primary and secondary endpoints
- Vaccine improves quality of life and symptom scores
Anergis, a company focusing on proprietary allergy vaccines, reported today that a Phase IIb study of its lead compound AllerT met the primary endpoint of reducing the combined symptom and medication score with AllerT 50 μg during the birch pollen season. Moreover, the vaccine improved the quality of life and symptom scores with AllerT 50 μg and AllerT 100 μg. 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.
In a placebo-controlled, double-blind, randomized multicenter trial, a total of 240 patients from 24 trial centers in Switzerland, France, Poland, Latvia, Lithuania, Sweden and Denmark were divided into three groups (placebo, AllerT 50 μg and AllerT 100 μg, respectively). From November 2012 to March 2013, the patients received 5 injections over a period of 2 months as a pre-seasonal treatment.
During the subsequent 2013 birch pollen season, compared to the placebo group, the combined Rhinoconjunctivitis Symptom and Medication Score (RSMS, primary endpoint) was reduced by 30% (p=0.024, statistically significant) with AllerT 50 μg and by 19% (p=0.190, not statistically significant) with AllerT 100 μg. Both AllerT doses were associated with similar statistically significant improvements in the total score of the Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) and in the rhinoconjunctivitis symptom score throughout the birch pollen season. All other secondary endpoints showed similar efficacy trends.
AllerT was safe and well-tolerated throughout the two-month pre-seasonal treatment. Most adverse events were mild or moderate, resolved within 24 hours, and there were no reports of anaphylactic shock or grade 3 allergic reactions within 30 minutes following any of the injections.
"With this study, we have now confirmed the efficacy of AllerT in a real-life, seasonal setting and are very satisfied with its safety profile," said Vincent Charlon, CEO of Anergis. "We are very confident that the efficacy of AllerT will be long-lasting, based on previously reported long-term antibody responses in our Phase I patients. We are therefore planning to proceed to Phase III as soon as possible in order to make AllerT available to allergy patients in the near future. Moreover, the results are very encouraging for the development of our follow-on pipeline products."
COP vaccines can be applied to a broad variety of allergy indications. Besides AllerT for the treatment of birch pollen allergies, Anergis' COP allergy vaccine pipeline currently includes AllerR for ragweed pollen allergies and AllerDM for dust mite allergies.
About Anergis' Contiguous Overlapping Peptides Technology (COPs)
The only curative therapy of allergies available today, known as "desensitization" or "Specific Immunotherapy" (SIT), 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 potential immediate (<30 min) anaphylactic reactions - which can be life-threatening. With its ultra-fast desensitization, Anergis is developing the future of allergy treatment. Anergis' vaccines are based on COPs (Contiguous Overlapping Peptides), 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 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. Studies of COPs targeting bee venom and birch pollen allergies in both animals and humans have demonstrated excellent safety (no immediate allergic reaction) and immunogenicity (production of specific antibodies and cytokines against the original allergen and establishment of a long-term immune memory). The Phase IIb data reported in September 2013 confirm that COP allergy vaccines can substantially reduce allergy symptoms under real-life conditions.
Anergis SA is a Swiss-based biopharmaceutical company specializing in the discovery and development of novel, proprietary allergy vaccines targeting commercially attractive indications. Anergis' vaccines are based on its IP-protected Contiguous Overlapping Peptide 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 in 2014. Two additional vaccine candidates against ragweed pollen allergies (AllerR) and against house dust mite allergies (AllerDM) are in preclinical development. Anergis has raised over CHF 22 million from Renaissance PME-Vinci Capital, Sunstone Capital, BioMedInvest and other investors, including Esperante Ventures and Defi Gestion.
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